Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®
| Group | Value |
|---|---|
| Gonal-f® + Ovitrelle® | not posted |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataShort name EXPRESS
This trial was stopped early.
Reason given at the registry: Study terminated due to recruitment failure
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
France
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Gonal-f® + Ovitrelle® + Long Agonist Protocol
Experimental
Gonal-f® + Ovitrelle® + Multi-dose Antagonist Protocol
Outcomes the sponsor listed as primary.
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).
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®
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.
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®
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.
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®
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).
Gene Expression in Participants Without Blastocyst Transfer
Time frame · Day 5 or 6 (window of implantation) after Oocyte Retrieval
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.
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
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).
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®
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.
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®
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Gonal-f® + Ovitrelle® | not posted |
| Group | Value (participants) |
|---|---|
| Gonal-f® + Ovitrelle® | 2 |
| Group | Value |
|---|---|
| Gonal-f® + Ovitrelle® (Long Agonist Protocol) | not posted |
| Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | not posted |
| Group | Value |
|---|---|
| Gonal-f® + Ovitrelle® (Long Agonist Protocol) | not posted |
| Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | not posted |
| Group | Value (participants) |
|---|---|
| Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 1 |
| Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 1 |
| Group | Value |
|---|---|
| Gonal-f® + Ovitrelle® (Long Agonist Protocol) | not posted |
| Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | not posted |
| Group | Value (participants) |
|---|---|
| Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 0 |
| Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | not posted |
| Group | Value |
|---|---|
| Gonal-f® + Ovitrelle® (Long Agonist Protocol) | not posted |
| Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 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. | – | 0 / 13 | 2 / 13 |
| 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 |
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