In Vitro FertilizationPhase 4EXPRESSNCT01210144
EXpression PRofile Endometrium Samples Study
A Phase 4 study testing Gonal -f® [r-hFSH], Ovitrelle® [r-hCG alfa] and Gonadotropin-releasing hormone (GnRH) Agonist in people with In Vitro Fertilization, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
Trial summary
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- Gonal -f® [r-hFSH], Ovitrelle® [r-hCG alfa] and Gonadotropin-releasing hormone (GnRH) Agonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2008to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile female or infertile male. Infertile female means diverse infertility etiologies including tubal disease (excepting hydrosalpinx) and so called "unexplained infertility"
- Suitable for ART: IVF undergoing first or second attempt, ICSI undergoing first attempt
- 18-35 years old, body mass index (BMI) less than or equal to 27 kilogram per square meter (kg/m^2), non smoking
- Normal ovarian status (FSH less than or equal to 9.45 International Units per Liter [IU/L], E2 less than or equal to 40 picogram per milliliter [pg/mL], Anti-Mullerian Hormone [AMH] greater than or equal to 18 picomole/liter [pmol/L]; within normal laboratory range values, normal ovaries sonography and uterine echo doppler)
- No history of active genito-urinary infection
- Normal thyroid function (or adequate substitution for at least 3 months)
Show all 11Show fewer
- Negative cervical papanicolaou test within the last 12 months prior to study entry
- No hormonal therapy, including gonadotropins and progesterone, for at least 2 months prior to the study
- In couple with female infertility, male partner with normal sperm or moderate oligoasthenospermia in semen analysis and negative semen culture less than 6 months at the study entry
- Willingness and ability to comply with the protocol for the duration of the study
- Written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
Who cannot join
- Subjects with ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
- Subjects with uterine malformation, diethylstilbestrol syndrome, adenomyosis, synechia
- Subjects with history of previous OHSS
- Subjects with polycystic ovarian syndrome (PCOS) according to the revised Rotterdam Consensus 2003
- Subjects with extra-uterine pregnancy during the previous 3 months
- Subjects with recurrent miscarriages (early or late, more than 2)
Show all 15Show fewer
- Subjects having known infection with human immunodeficiency virus (HIV), hepatitis B or C virus, for subject or partner
- Subjects with abnormal gynecological bleeding of undetermined origin
- Subjects with history of major thromboembolic disease
- Subjects with endometriosis
- Subjects with presence or history of malignant tumors and related treatment
- Subjects with clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening
- Subjects with known allergy or hypersensitivity to Gonal-f® or Ovitrelle®
- Subjects with any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years
- Subjects who have participated within 3 months prior to study entry in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Pilot Study on Gene Expression Profiling of the Endometrial Tissue in Patients Undergoing Assisted Reproductive Technology [ART: In Vitro Fertilization (IVF)/ Intracytoplasmic Sperm Injection (ICSI)] With GONAL-f®
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest.
The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.
Read the detailed description
This is a pilot open-label, national, multi-centre, Phase IV trial. This trial will be conducted with outpatients. Once subject has met all eligibility criteria, she will be treated with Gonal-f® prefilled pen and will receive on a randomization basis the GnRH agonist or antagonist. The follicle stimulating hormone (FSH) stimulation will start on day 2 of the menstrual cycle with a pre-defined fixed dose of 150 IU per day until follicles are recruited and developed. Dose adjustment will be allowed strictly in case of risk of ovarian hyperstimulation syndrome (OHSS). Ovulation triggering will be performed using a single injection of 250 mcg Ovitrelle®.
Ultrasound scans (US) will be performed concomitantly with hormonal assessment at each visit. Ovulation will be triggered as soon as there are at least 3 follicles > 16 mm, and with E2 > 1 mcg/L if agonist used. Oocyte retrieval, in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) and blastocyst transfer will be performed as per centre's standard practice. Vaginal progesterone will be administered in the luteal phase for all subjects (600 milligram per day [mg/d]).
Hormonal assessment and endometrial biopsy will be performed on:
- Day Luteinizing Hormone+7 ("LH+7") of the previous spontaneous cycle
- Day of Oocyte Retrieval (OR) of the stimulated cycle
- Day "OR+5 or 6" (biopsy performed only in subjects that did not have blastocyst(s) transfer).
Gene expression profiling will be carried out on ribonucleic acid (RNA) from endometrial tissue. As the main objective of this trial is to determine the gene expression profiles of endometrial tissue before and after controlled ovarian stimulation with Gonal-f®, a minimum of 2 endometrial samples per subject will be collected, 1 at day LH+7 of spontaneous cycle and 1 after the stimulation, on the day of OR.
The subjects will be followed up until 15 days after the last injection of Investigational Medicinal Products (IMPs) for the safety assessment. For subjects who will have blastocyst implantation, the pregnancy outcomes will be recorded until 12 weeks of gestation if a pregnancy is ongoing up to that period.
OBJECTIVES
Primary objective:
- To determine the gene expression profile and histological changes of endometrial tissue before (at day LH + 7 of spontaneous cycle) and after stimulation with Gonal-f® (Day of OR: 36 +/- 2 hours post r-hCG administration) in Assisted Reproductive Technology (ART) [IVF/ICSI]
Secondary objectives:
- To correlate the gene expression profile of the endometrial tissue at Day LH + 7 of the spontaneous cycle with the blastocyst implantation rate in subjects undergoing ART with Gonal-f®
- To correlate the gene expression profile and histological changes in endometrial tissue before and after stimulation by Gonal-f® with the "down regulation" protocol used (agonist or antagonist) and fertilization mode, IVF/ICSI
- To correlate the gene expression profile and histological changes in endometrial tissue before and after stimulation by Gonal-f® according to the hormonal status of subjects
- To characterize the gene expression profile and histology of endometrial tissue after stimulation with Gonal-f in subjects without blastocyst during the theoretical window of implantation (OR + 5 or 6 days)
- To characterize the gene expression profile and histology of endometrial tissue of good and poor responders to stimulation with Gonal-f® on the Day of OR (response being based on the following criteria):
- Quantity of mature oocytes retrieved:
- Poor responders: 5 mature oocytes or less
- Good responders: more than 8 mature oocytes
- Quantity of Gonal-f® used
- Conditions
- In Vitro Fertilization
- Being tested
- Gonal -f® [r-hFSH], Ovitrelle® [r-hCG alfa], Gonadotropin-releasing hormone (GnRH) Agonist, Gonadotropin-releasing hormone (GnRH) Antagonist
- Keywords
- Infertility, Gonal-f, gene expression, Assisted Reproductive Technologies, Follitropin alfa, endometrium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonal -f® [r-hFSH]Drug
Also called Gonal-f®, Follitropin Alfa
On Day 2 of the menstrual cycle, a pre-defined fixed dose of 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH) will be administered until follicles are recruited and developed.
Ovitrelle® [r-hCG alfa]Drug
Also called Ovitrelle®, Ovidrel®
Ovulation triggering will be performed using a single injection of 250 microgram (mcg) recombinant human chorionic gonadotropin (r-hCG) alfa as soon as follicles satisfy the criteria for follicular development, that is at least 3 follicles greater than (>) 16 millimeter (mm), and with estradiol (E2) > 1 microgram per liter (mcg/L) if gonadotropin releasing hormone (GnRH) agonist will be used.
Gonadotropin-releasing hormone (GnRH) AgonistDrug
To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily will be given after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
Gonadotropin-releasing hormone (GnRH) AntagonistDrug
To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily will be given from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
| Study group | Role | What they receive |
|---|---|---|
| Gonal-f® + Ovitrelle® + Long Agonist Protocol | Experimental | Not described Receives: Drug: Gonal -f® [r-hFSH]; Drug: Ovitrelle® [r-hCG alfa]; Drug: Gonadotropin-releasing hormone (GnRH) Agonist |
| Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol | Experimental | Not described Receives: Drug: Gonal -f® [r-hFSH]; Drug: Ovitrelle® [r-hCG alfa]; Drug: Gonadotropin-releasing hormone (GnRH) Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®
A list of genes based on gene expression profiling carried out on ribonucleic acid (RNA) extracted from endometrial tissue. The expression of messenger ribonucleic acid (mRNA) in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Measured: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f®
Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle) and Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).
Measured: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Secondary outcomes (7)
Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer
A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Measured: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol
A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Measured: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol
Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).
Measured: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Gene Expression in Participants Without Blastocyst Transfer
A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Measured: Day 5 or 6 (window of implantation) after Oocyte Retrieval
Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer
Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).
Measured: Day 5 or 6 (window of implantation) after Oocyte Retrieval
Gene Expression in Participants With Good or Poor Response to Gonal-f®
A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent. Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.
Measured: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f®
Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase). Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.
Measured: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Study terminated due to recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A.S, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210144
- Sponsor's protocol ID
- IMP 28364
- Other IDs
- 2007-003938-41
- Acronym
- EXPRESS
- Status last verified
- Dec 2013
- First submitted
- 11 Aug 2010
- Last updated
- 27 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Pilot Study on Gene Expression Profiling of the Endometrial Tissue in Patients Undergoing Assisted Reproductive Technology [ART: In Vitro Fertilization (IVF)/ Intracytoplasmic Sperm Injection (ICSI)] With GONAL-f®
- ClinicalTrials.gov ID
- NCT01210144
- Acronym / sponsor ID
- EXPRESS / IMP 28364
- Conditions
- In Vitro Fertilization
- Keywords
- Infertility, Gonal-f, gene expression, Assisted Reproductive Technologies, Follitropin alfa, endometrium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to recruitment failure
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A.S, France
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Posted 14 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest.
The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.
Detailed description
This is a pilot open-label, national, multi-centre, Phase IV trial. This trial will be conducted with outpatients. Once subject has met all eligibility criteria, she will be treated with Gonal-f® prefilled pen and will receive on a randomization basis the GnRH agonist or antagonist. The follicle stimulating hormone (FSH) stimulation will start on day 2 of the menstrual cycle with a pre-defined fixed dose of 150 IU per day until follicles are recruited and developed. Dose adjustment will be allowed strictly in case of risk of ovarian hyperstimulation syndrome (OHSS). Ovulation triggering will be performed using a single injection of 250 mcg Ovitrelle®.
Ultrasound scans (US) will be performed concomitantly with hormonal assessment at each visit. Ovulation will be triggered as soon as there are at least 3 follicles > 16 mm, and with E2 > 1 mcg/L if agonist used. Oocyte retrieval, in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) and blastocyst transfer will be performed as per centre's standard practice. Vaginal progesterone will be administered in the luteal phase for all subjects (600 milligram per day [mg/d]).
Hormonal assessment and endometrial biopsy will be performed on:
- Day Luteinizing Hormone+7 ("LH+7") of the previous spontaneous cycle
- Day of Oocyte Retrieval (OR) of the stimulated cycle
- Day "OR+5 or 6" (biopsy performed only in subjects that did not have blastocyst(s) transfer).
Gene expression profiling will be carried out on ribonucleic acid (RNA) from endometrial tissue. As the main objective of this trial is to determine the gene expression profiles of endometrial tissue before and after controlled ovarian stimulation with Gonal-f®, a minimum of 2 endometrial samples per subject will be collected, 1 at day LH+7 of spontaneous cycle and 1 after the stimulation, on the day of OR.
The subjects will be followed up until 15 days after the last injection of Investigational Medicinal Products (IMPs) for the safety assessment. For subjects who will have blastocyst implantation, the pregnancy outcomes will be recorded until 12 weeks of gestation if a pregnancy is ongoing up to that period.
OBJECTIVES
Primary objective:
- To determine the gene expression profile and histological changes of endometrial tissue before (at day LH + 7 of spontaneous cycle) and after stimulation with Gonal-f® (Day of OR: 36 +/- 2 hours post r-hCG administration) in Assisted Reproductive Technology (ART) [IVF/ICSI]
Secondary objectives:
- To correlate the gene expression profile of the endometrial tissue at Day LH + 7 of the spontaneous cycle with the blastocyst implantation rate in subjects undergoing ART with Gonal-f®
- To correlate the gene expression profile and histological changes in endometrial tissue before and after stimulation by Gonal-f® with the "down regulation" protocol used (agonist or antagonist) and fertilization mode, IVF/ICSI
- To correlate the gene expression profile and histological changes in endometrial tissue before and after stimulation by Gonal-f® according to the hormonal status of subjects
- To characterize the gene expression profile and histology of endometrial tissue after stimulation with Gonal-f in subjects without blastocyst during the theoretical window of implantation (OR + 5 or 6 days)
- To characterize the gene expression profile and histology of endometrial tissue of good and poor responders to stimulation with Gonal-f® on the Day of OR (response being based on the following criteria):
- Quantity of mature oocytes retrieved:
- Poor responders: 5 mature oocytes or less
- Good responders: more than 8 mature oocytes
- Quantity of Gonal-f® used
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gonal-f® + Ovitrelle® + Long Agonist Protocol | Experimental | Drug: Gonal -f® [r-hFSH], Drug: Ovitrelle® [r-hCG alfa], Drug: Gonadotropin-releasing hormone (GnRH) Agonist |
| Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol | Experimental | Drug: Gonal -f® [r-hFSH], Drug: Ovitrelle® [r-hCG alfa], Drug: Gonadotropin-releasing hormone (GnRH) Antagonist |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Infertile female or infertile male. Infertile female means diverse infertility etiologies including tubal disease (excepting hydrosalpinx) and so called "unexplained infertility"
- Suitable for ART: IVF undergoing first or second attempt, ICSI undergoing first attempt
- 18-35 years old, body mass index (BMI) less than or equal to 27 kilogram per square meter (kg/m^2), non smoking
- Normal ovarian status (FSH less than or equal to 9.45 International Units per Liter [IU/L], E2 less than or equal to 40 picogram per milliliter [pg/mL], Anti-Mullerian Hormone [AMH] greater than or equal to 18 picomole/liter [pmol/L]; within normal laboratory range values, normal ovaries sonography and uterine echo doppler)
- No history of active genito-urinary infection
Key exclusion criteria (15 listed)
- Subjects with ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
- Subjects with uterine malformation, diethylstilbestrol syndrome, adenomyosis, synechia
- Subjects with history of previous OHSS
- Subjects with polycystic ovarian syndrome (PCOS) according to the revised Rotterdam Consensus 2003
- Subjects with extra-uterine pregnancy during the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonal -f® [r-hFSH]Also: Gonal-f®, Follitropin AlfaOn Day 2 of the menstrual cycle, a pre-defined fixed dose of 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH) will be administered until follicles are recruited and developed. | Drug | Gonal-f® + Ovitrelle® + Long Agonist Protocol, Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol |
| Ovitrelle® [r-hCG alfa]Also: Ovitrelle®, Ovidrel®Ovulation triggering will be performed using a single injection of 250 microgram (mcg) recombinant human chorionic gonadotropin (r-hCG) alfa as soon as follicles satisfy the criteria for follicular development, that is at least 3 follicles greater than (>) 16 millimeter (mm), and with estradiol (E2) > 1 microgram per liter (mcg/L) if gonadotropin releasing hormone (GnRH) agonist will be used. | Drug | Gonal-f® + Ovitrelle® + Long Agonist Protocol, Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol |
| Gonadotropin-releasing hormone (GnRH) AgonistTo prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily will be given after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol. | Drug | Gonal-f® + Ovitrelle® + Long Agonist Protocol |
| Gonadotropin-releasing hormone (GnRH) AntagonistTo prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily will be given from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol. | Drug | Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol |
Primary outcome
Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®
Time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
A list of genes based on gene expression profiling carried out on ribonucleic acid (RNA) extracted from endometrial tissue. The expression of messenger ribonucleic acid (mRNA) in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f®
Time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle) and Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).
7 secondary outcomes
Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer
Time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol
Time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol
Time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Gene Expression in Participants Without Blastocyst Transfer
Time frame: Day 5 or 6 (window of implantation) after Oocyte Retrieval
Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer
Time frame: Day 5 or 6 (window of implantation) after Oocyte Retrieval
Gene Expression in Participants With Good or Poor Response to Gonal-f®
Time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f®
Time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for In Vitro Fertilization
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
RecruitingPhase 3
Fertilo In Vitro Research Study and Trial
In Vitro Maturation of Oocytes
Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
Active, not recruiting
Interest of Morphokinetic Parameters of Early Embryonic Development in the Birth Rates in Vitro Fertilization
Reproductive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gonal -f® [r-hFSH], Ovitrelle® [r-hCG alfa] and Gonadotropin-releasing hormone (GnRH) Agonist in people with In Vitro Fertilization, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® (time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2013.