InfertilityPhase 4CONSORTNCT00249834
Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)
A Phase 4 study testing Gonal-f and Recombinant human chorionic gonadotrophin (r-hCG) in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
Trial summary
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Gonal-f and Recombinant human chorionic gonadotrophin (r-hCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2004to 16 Jan 2006
- 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 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be an infertile subject justifying an in-vitro fertilization/embryo transfer (IVF/ET) treatment.
- Have a male partner with semen analysis within the past six months prior to study entry considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used.
- Be between her 18th and 35th birthday (35 not included).
- Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length.
- Have early follicular phase (Day 2-4) serum levels within the last 3 months prior to study entry of:
- Follicle stimulating hormone (FSH) greater than or equal to (>=) 12 International units per liter (IU/L), and
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- Oestradiol (E2) within center's local normal laboratory range values.
- Presence of both ovaries.
- Have a uterine cavity without abnormalities, which, in the investigator's opinion, could impair embryo implantation or pregnancy evolution as assessed within the last 3 years using ultrasound (US), hysteroscopy (HSC), or hysterosalpingography (HSG).
- Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to study entry.
- Have at least one wash-out cycle (defined as >= 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin releasing hormone (GnRH) agonist therapy.
- Have a negative pregnancy test prior to beginning GnRH agonist therapy.
- Be willing and able to comply with the protocol for the duration of the study. Have given 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 her future medical care.
Who cannot join
- Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined as less than or equal to (<=) 5 mature follicles and/or <=3 oocytes collected in any previous IVF cycle or hyper response, defined as >=25 oocytes retrieved.
- Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Serono's Therapeutic Director.
- Had previous severe ovarian hyperstimulation syndrome (OHSS).
- A body mass index (BMI) greater than (>) 30 kilogram per square meter (kg/m^2)
- Any contraindication to being pregnant and/or carrying a pregnancy to term.
- Extra-uterine pregnancy within the last 3 months.
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- History of 3 or more miscarriages (early or late miscarriages) due to any cause.
- Tumours of the hypothalamus and pituitary gland.
- Ovarian enlargement or cyst of unknown aetiology.
- Ovarian, uterine or mammary cancer.
- A clinically significant systemic disease.
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus.
- Abnormal gynaecological bleeding of undetermined origin.
- Known allergy or hypersensitivity to human gonadotrophin preparations.
- Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years.
- Entered previously into this study or simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.
- Conditions
- Infertility
- Being tested
- Gonal-f, Recombinant human chorionic gonadotrophin (r-hCG)
- Keywords
- Assisted Reproductive Technology (ART), Infertility, Ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonal-fDrug
Also called follitropin alfa, Recombinant Human Follicle Stimulating Hormone (r-hFSH)
GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.
Recombinant human chorionic gonadotrophin (r-hCG)Drug
When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Gonal-f 112.5 IU | Experimental | Not described Receives: Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 37.5 IU | Experimental | Not described Receives: Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 75 IU | Experimental | Not described Receives: Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 150 IU | Experimental | Not described Receives: Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 187.5 IU | Experimental | Not described Receives: Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 225 IU | Experimental | Not described Receives: Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 262.5 IU | Experimental | Not described Receives: Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 300 IU | Experimental | Not described Receives: Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Measured: Ovum pick up day (34 to 38 hours post r-hCG administration)
Secondary outcomes (7)
Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Measured: up to end of stimulation cycle (approximately 31 days)
Mean Number of Ovarian Stimulation Days
The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Measured: up to end of stimulation cycle (approximately 31 days)
Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH
As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Measured: up to end of stimulation cycle (approximately 31 days)
Number of Subjects Needing Dose Adjustment
Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Measured: 6 days post r-hFSH treatment
Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose
As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Measured: up to end of stimulation cycle (approximately 31 days)
Embryo Implantation Rate
Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Measured: 35-42 days post r-hCG administration
Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate
Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Measured: 35-42 days post r-hCG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study start22 Sep 2004
- Primary completion16 Jan 2006
- Study completion16 Jan 2006
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249834
- Sponsor's protocol ID
- 25198
- Acronym
- CONSORT
- Status last verified
- Aug 2017
- First submitted
- 4 Nov 2005
- Last updated
- 30 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Olivennes F, Howles CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V; CONSORT study group. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2009 Feb;18(2):195-204. doi: 10.1016/s1472-6483(10)60256-8.
PubMed 19192339Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6.
PubMed 21575853
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT00249834
- Acronym / sponsor ID
- CONSORT / 25198
- Conditions
- Infertility
- Keywords
- Assisted Reproductive Technology (ART), Infertility, Ovarian stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2004 (actual)
- Primary completion
- 16 Jan 2006 (actual)
- Study completion
- 16 Jan 2006 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Posted 30 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Gonal-f 112.5 IU | Experimental | Drug: Gonal-f, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 37.5 IU | Experimental | Drug: Gonal-f, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 75 IU | Experimental | Drug: Gonal-f, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 150 IU | Experimental | Drug: Gonal-f, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 187.5 IU | Experimental | Drug: Gonal-f, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 225 IU | Experimental | Drug: Gonal-f, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 262.5 IU | Experimental | Drug: Gonal-f, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
| Gonal-f 300 IU | Experimental | Drug: Gonal-f, Drug: Recombinant human chorionic gonadotrophin (r-hCG) |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Be an infertile subject justifying an in-vitro fertilization/embryo transfer (IVF/ET) treatment.
- Have a male partner with semen analysis within the past six months prior to study entry considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used.
- Be between her 18th and 35th birthday (35 not included).
- Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length.
- Have early follicular phase (Day 2-4) serum levels within the last 3 months prior to study entry of:
Key exclusion criteria (16 listed)
- Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined as less than or equal to (<=) 5 mature follicles and/or <=3 oocytes collected in any previous IVF cycle or hyper response, defined as >=25 oocytes retrieved.
- Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Serono's Therapeutic Director.
- Had previous severe ovarian hyperstimulation syndrome (OHSS).
- A body mass index (BMI) greater than (>) 30 kilogram per square meter (kg/m^2)
- Any contraindication to being pregnant and/or carrying a pregnancy to term.
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-fAlso: follitropin alfa, Recombinant Human Follicle Stimulating Hormone (r-hFSH)GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. | Drug | Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU, Gonal-f 225 IU, Gonal-f 262.5 IU, Gonal-f 300 IU, Gonal-f 37.5 IU, Gonal-f 75 IU |
| Recombinant human chorionic gonadotrophin (r-hCG)When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered. | Drug | Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU, Gonal-f 225 IU, Gonal-f 262.5 IU, Gonal-f 300 IU, Gonal-f 37.5 IU, Gonal-f 75 IU |
Primary outcome
Number of Oocytes Retrieved
Time frame: Ovum pick up day (34 to 38 hours post r-hCG administration)
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
7 secondary outcomes
Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
Time frame: up to end of stimulation cycle (approximately 31 days)
Mean Number of Ovarian Stimulation Days
Time frame: up to end of stimulation cycle (approximately 31 days)
Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH
Time frame: up to end of stimulation cycle (approximately 31 days)
Number of Subjects Needing Dose Adjustment
Time frame: 6 days post r-hFSH treatment
Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose
Time frame: up to end of stimulation cycle (approximately 31 days)
Embryo Implantation Rate
Time frame: 35-42 days post r-hCG administration
Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate
Time frame: 35-42 days post r-hCG administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19192339Olivennes F, Howles CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V; CONSORT study group. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2009 Feb;18(2):195-204. doi: 10.1016/s1472-6483(10)60256-8.
- Results publication: PubMed 21575853Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
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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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
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 and Recombinant human chorionic gonadotrophin (r-hCG) in people with Infertility, 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 13 inclusion and 16 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: finished, as of the sponsor's last update on 30 Mar 2018. 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 30 Mar 2018). 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?
Number of Oocytes Retrieved (time frame: Ovum pick up day (34 to 38 hours post r-hCG administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249834, which also lists 2 linked publications.
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 30 Mar 2018.