Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003938-41 | EudraCT Number |
Not provided
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Study terminated due to recruitment failure
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| Name | Class |
|---|---|
| Merck Serono S.A.S, France | INDUSTRY |
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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.
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:
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:
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:
Quantity of Gonal-f® used
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gonal-f® + Ovitrelle® + Long Agonist Protocol | Experimental |
| |
| Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonal -f® [r-hFSH] | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
Not provided
Not provided
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Paris | France |
A total of 27 participants were enrolled in the study, out of which 2 participants withdrew the consent and 1 participant was excluded since endometrial biopsy was not possible.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) gonadotropin-releasing hormone (GnRH) agonist daily was started 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. |
| FG001 | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data were not analyzed for both agonist and antagonist protocol as total, which was the primary objective, since gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study. | Posted | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
|
Up to 15 days after the last Investigational Medicinal Product (IMP) administration or early termination
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerge or worsen relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
Gene expression of the endometrium could not be analyzed due to poor quality of biopsy samples (poor mRNA quality) and poor recruitment in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015292 | Glycoprotein Hormones, alpha Subunit |
| C571801 | follitropin alfa |
| D006063 | Chorionic Gonadotropin |
| C412828 | Ovidrel |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ovitrelle® [r-hCG alfa] | Drug | 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) Agonist | Drug | 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) Antagonist | Drug | 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. |
|
| 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. | 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). | 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. | 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). | 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. | 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. | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
| No transfer |
|
| BG001 | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | 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). | Intention-to-Treat (ITT) population: participants who received at least 1 dose of study drug. "N" (number of participants analyzed) signifies participants evaluable for this measure. Results for both agonist and antagonist protocol are presented as total since assessment of histological pattern for whole study population was the primary objective. | Posted | Number | participants | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
|
|
|
| Secondary | 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. | Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study. | Posted | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
|
|
| Secondary | 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. | Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study. | Posted | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
|
|
| Secondary | 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). | ITT population included those participants who received at least one dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
|
|
|
| Secondary | 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. | Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study. | Posted | Day 5 or 6 (window of implantation) after Oocyte Retrieval |
|
|
| Secondary | 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). | ITT population: participants who received at least one dose of study medication. "N" (number of participants analyzed) signifies participants who were evaluable for this measure. Data were not analyzed for Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) group because there were no participants without blastocyst transfer in this group. | Posted | Number | participants | Day 5 or 6 (window of implantation) after Oocyte Retrieval |
|
|
|
| Secondary | 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. | Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study. | Posted | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
|
|
| Secondary | 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. | Data for histological pattern of the endometrium in participants with good or poor response to Gonal-f were not summarized because the number of participants in each group with respect to ovarian response were too low. | Posted | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® |
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol. | 0 | 11 | 1 | 11 |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Not provided
| D005640 | Follicle Stimulating Hormone |
| D006065 | Gonadotropins, Pituitary |
| D007986 | Luteinizing Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| Title | Measurements |
|---|---|
|
| Intermediate secretory phase |
|
| Title | Measurements |
|---|---|
|