InfertilityPhase 2NCT01075815
A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age
A Phase 2 study testing Recombinant human luteinizing hormone (rhLH) and Recombinant follicle-stimulating hormone (rFSH) in people with Infertility and Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Spain.
Trial summary
This is a multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms of improved embryo competence which allows to transfer less embryos to avoid high grade… Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Infertility, Ovulation Induction
- What is being tested?
- Recombinant human luteinizing hormone (rhLH) and Recombinant follicle-stimulating hormone (rFSH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2008to Oct 2010
- Phase
- Phase 2
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-menopausal female subject aged greater than (>) 35 years
- Subjects with baseline FSH serum level less than or equal to (<=) 10 IU/liter (l), LH and E2 levels within local normal range and plasma prolactin levels < 30 nanogram/milliliter (ng/ml)
- Subjects with regular spontaneous menstrual cycles of 25-35 days
- Subjects with infertility justifying IVF/ICSI-ET treatment
- Subjects programmed for COS with r-FSH under GnRH agonist protocol
- Sperm from current male partner suitable for IVF/ICSI according to local lab, unless sperm donor is foreseen
Show all 13Show fewer
- Subjects with presence of both ovaries
- Subjects whose uterine cavity is able to sustain embryo implantation or pregnancy
- Subjects with normal papanicolaou test (PAP) smear within previous 3 years
- Subjects with body mass index (BMI) < 30 at stimulation start
- Subjects who receive confirmation of not being pregnant by a negative beta-hCG test (urine or blood) prior to starting r-FSH administration
- Subjects willing and able to comply with the protocol for the duration of the study
- Subjects who have given informed consent prior to any study-related procedure not part of normal medical care
Who cannot join
- Subjects or her male partners who are known to be human immunodeficiency virus, hepatitis B virus or hepatitis C virus positive
- Subjects with any clinically significant systemic disease; tumors of the hypothalamus and pituitary gland; ovarian, uterine or mammary cancer; hormonal abnormality and/or medical, biochemical, hematological condition which in the judgment of the investigator may interfere with gonadotropin treatment
- Subjects with more than 2 previous assisted reproductive technologies (ART) cycles
- Subjects in which previous cycles were cancelled due to poor response (< 3 antral follicles after 15 day of stimulation)
- Subjects with cryopreserved embryos from previous ART cycles
- Subjects with unexplained gynecological bleeding
Show all 12Show fewer
- Subjects with polycystic ovaries, ovarian enlargement or cyst of unknown etiology
- Subjects known to have any contraindication to being pregnant and/or carrying pregnancy to term
- Subjects with known allergy to gonadotrophin preparations or any of the excipients
- Subjects known to have any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years
- Subjects with previous entry into this study or simultaneous participation in another clinical drug trial
- Subjects who have refused to or inability to comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study to Determine the Effect of Lutropin Alfa on Embryo Quality and Their Implantation in Women of Advanced Reproductive Age
This is a multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms of improved embryo competence which allows to transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy rate.
Read the detailed description
This study will be carried out by the Grupo de Interés de Salud Embrionaria (GISE) group (part of the Spanish Fertility Society) who uses strict criteria to select the embryos most suitable for successful transference.
OBJECTIVES
Primary objective:
- To determine the benefit of r-LH supplementation in COS prior to in-vitro fertilization (IVF)/intracytosolic sperm injection (ICSI) in advanced reproductive age, in terms of embryo competence to implant, as compared against no r-LH supplementation
Secondary objectives:
To evaluate the benefit of r-LH supplementation in COS, in terms of:
- follicular development
- length of the stimulation
- oocyte number and their maturity
- fertilization rate
- embryo number and quality
- gestational sacs
- abortion
- ongoing pregnancies
- local and systemic safety of r-LH administration
The study will consist of 2 groups randomized in 1:1 ratio and each subject would be followed up until the confirmation of her pregnancy status. Each subject will be administered gonadotropin releasing hormone (GnRH) agonist subcutaneously daily from previous mid luteal phase to r-hCG administration as a standard practice to achieve down regulation. Each subject will also be administered recombinant follicle stimulating hormone (r-FSH) at a starting dose of 300 IU from S1 up to ovarian stimulation completion (r-hCG day) as a part of standard practice. In addition to the above concurrent therapies, one group will be administered experimental treatment (Luveris®) and the other group (control group) will not be administered any other drug (control treatment) during the stimulation period from stimulation start (S1) up to ovarian stimulation completion or stimulation cancellation respectively. Ovarian stimulation on an average takes 11 days and it is expected that stimulation period will not be extended beyond 15 days. A single injection of r-hCG will be administered intramuscularly or subcutaneously after the last injection of Luveris or r-FSH to achieve final follicular maturation. After, 34-36 hours of administration of r-hCG OPU will be done for oocyte retrieval and embryo transfer (ET) will be conducted within 5 days from OPU. Subjects will also be provided luteal support with natural progesterone and will be followed until delivery or miscarriage. Ultrasound and estradiol (E2) assessment of follicular growth will be conducted at various time points during the stimulation period with or without treatment adjustment.
- Conditions
- Infertility, Ovulation Induction
- Being tested
- Recombinant human luteinizing hormone (rhLH), Recombinant follicle-stimulating hormone (rFSH)
- Keywords
- Infertility, Ovulation induction, Luveris, Controlled ovarian stimulation, Reproductive technologies, assisted
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human luteinizing hormone (rhLH)Drug
Also called Luveris®, Lutropin alfa
Recombinant follicle-stimulating hormone (rFSH)Drug
| Study group | Role | What they receive |
|---|---|---|
| rFSH + rhLH | Experimental | Recombinant human luteinizing hormone (rhLH,Luveris®) injection 150 IU subcutaneously daily along with rFSH 300 IU subcutaneously daily from S1 to S4 and then rFSH dose can be adjusted depending on the ovarian response till r-hCG administration day. Receives: Drug: Recombinant human luteinizing hormone (rhLH); Drug: Recombinant follicle-stimulating hormone (rFSH) |
| rFSH | Active comparator | rFSH injection 300 IU subcutaneously daily from S1 to S4 and then dose can be adjusted depending on the ovarian response till r-hCG administration day. Receives: Drug: Recombinant follicle-stimulating hormone (rFSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation Rate
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.
Measured: Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])
Secondary outcomes (15)
Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day
Measured: r-hCG day (end of stimulation cycle [approximately 28 days])
Mean Number of Oocytes Retrieved
Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Measured: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Mature Oocytes Retrieved
Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage.
Measured: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Fertilized Oocytes (2 Pronuclei [PN])
Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
Measured: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Number and Quality of Embryos
Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation.
Measured: Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])
Number of Participants With Biochemical Pregnancies
Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy.
Measured: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Number of Participants With Clinical Pregnancies
Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Measured: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Measured: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Estradiol (E2) Levels on r-hCG Day
Measured: r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Ovarian Stimulation Days
Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met.
Measured: S1 up to r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response
Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.
Measured: Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Total Number of Births
Total number of births per reporting group was calculated.
Measured: Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Measured: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Measured: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionOct 2010
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck, S.L., Spain
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck, S.L., Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075815
- Sponsor's protocol ID
- 700642-500
- Other IDs
- 2008-002281-55, 2008
- Status last verified
- Jan 2014
- First submitted
- 24 Feb 2010
- Last updated
- 13 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Determine the Effect of Lutropin Alfa on Embryo Quality and Their Implantation in Women of Advanced Reproductive Age
- ClinicalTrials.gov ID
- NCT01075815
- Acronym / sponsor ID
- 700642-500
- Conditions
- Infertility, Ovulation Induction
- Keywords
- Infertility, Ovulation induction, Luveris, Controlled ovarian stimulation, Reproductive technologies, assisted
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck, S.L., Spain
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Posted 20 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 multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms of improved embryo competence which allows to transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy rate.
Detailed description
This study will be carried out by the Grupo de Interés de Salud Embrionaria (GISE) group (part of the Spanish Fertility Society) who uses strict criteria to select the embryos most suitable for successful transference.
OBJECTIVES
Primary objective:
- To determine the benefit of r-LH supplementation in COS prior to in-vitro fertilization (IVF)/intracytosolic sperm injection (ICSI) in advanced reproductive age, in terms of embryo competence to implant, as compared against no r-LH supplementation
Secondary objectives:
To evaluate the benefit of r-LH supplementation in COS, in terms of:
- follicular development
- length of the stimulation
- oocyte number and their maturity
- fertilization rate
- embryo number and quality
- gestational sacs
- abortion
- ongoing pregnancies
- local and systemic safety of r-LH administration
The study will consist of 2 groups randomized in 1:1 ratio and each subject would be followed up until the confirmation of her pregnancy status. Each subject will be administered gonadotropin releasing hormone (GnRH) agonist subcutaneously daily from previous mid luteal phase to r-hCG administration as a standard practice to achieve down regulation. Each subject will also be administered recombinant follicle stimulating hormone (r-FSH) at a starting dose of 300 IU from S1 up to ovarian stimulation completion (r-hCG day) as a part of standard practice. In addition to the above concurrent therapies, one group will be administered experimental treatment (Luveris®) and the other group (control group) will not be administered any other drug (control treatment) during the stimulation period from stimulation start (S1) up to ovarian stimulation completion or stimulation cancellation respectively. Ovarian stimulation on an average takes 11 days and it is expected that stimulation period will not be extended beyond 15 days. A single injection of r-hCG will be administered intramuscularly or subcutaneously after the last injection of Luveris or r-FSH to achieve final follicular maturation. After, 34-36 hours of administration of r-hCG OPU will be done for oocyte retrieval and embryo transfer (ET) will be conducted within 5 days from OPU. Subjects will also be provided luteal support with natural progesterone and will be followed until delivery or miscarriage. Ultrasound and estradiol (E2) assessment of follicular growth will be conducted at various time points during the stimulation period with or without treatment adjustment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rFSH + rhLH | Experimental | Drug: Recombinant human luteinizing hormone (rhLH), Drug: Recombinant follicle-stimulating hormone (rFSH)Recombinant human luteinizing hormone (rhLH,Luveris®) injection 150 IU subcutaneously daily along with rFSH 300 IU subcutaneously daily from S1 to S4 and then rFSH dose can be adjusted depending on the ovarian response till r-hCG administration day. |
| rFSH | Active comparator | Drug: Recombinant follicle-stimulating hormone (rFSH)rFSH injection 300 IU subcutaneously daily from S1 to S4 and then dose can be adjusted depending on the ovarian response till r-hCG administration day. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pre-menopausal female subject aged greater than (>) 35 years
- Subjects with baseline FSH serum level less than or equal to (<=) 10 IU/liter (l), LH and E2 levels within local normal range and plasma prolactin levels < 30 nanogram/milliliter (ng/ml)
- Subjects with regular spontaneous menstrual cycles of 25-35 days
- Subjects with infertility justifying IVF/ICSI-ET treatment
- Subjects programmed for COS with r-FSH under GnRH agonist protocol
Key exclusion criteria (12 listed)
- Subjects or her male partners who are known to be human immunodeficiency virus, hepatitis B virus or hepatitis C virus positive
- Subjects with any clinically significant systemic disease; tumors of the hypothalamus and pituitary gland; ovarian, uterine or mammary cancer; hormonal abnormality and/or medical, biochemical, hematological condition which in the judgment of the investigator may interfere with gonadotropin treatment
- Subjects with more than 2 previous assisted reproductive technologies (ART) cycles
- Subjects in which previous cycles were cancelled due to poor response (< 3 antral follicles after 15 day of stimulation)
- Subjects with cryopreserved embryos from previous ART cycles
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 |
|---|---|---|
| Recombinant human luteinizing hormone (rhLH)Also: Luveris®, Lutropin alfa | Drug | rFSH + rhLH |
| Recombinant follicle-stimulating hormone (rFSH) | Drug | rFSH, rFSH + rhLH |
Primary outcome
Implantation Rate
Time frame: Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.
15 secondary outcomes
Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day
Time frame: r-hCG day (end of stimulation cycle [approximately 28 days])
Mean Number of Oocytes Retrieved
Time frame: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Mature Oocytes Retrieved
Time frame: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Fertilized Oocytes (2 Pronuclei [PN])
Time frame: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Number and Quality of Embryos
Time frame: Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])
Number of Participants With Biochemical Pregnancies
Time frame: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Number of Participants With Clinical Pregnancies
Time frame: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Time frame: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Estradiol (E2) Levels on r-hCG Day
Time frame: r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Ovarian Stimulation Days
Time frame: S1 up to r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response
Time frame: Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Total Number of Births
Time frame: Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)
Time frame: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)
Time frame: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, S.L., Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human luteinizing hormone (rhLH) and Recombinant follicle-stimulating hormone (rFSH) in people with Infertility and Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Spain.
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 12 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 13 Feb 2014. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 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?
Implantation Rate (time frame: Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])). 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 13 Feb 2014.