Trial · NCT01210144
EXpression PRofile Endometrium Samples Study
NCT01210144, Phase 4, Terminated, Merck KGaA, Darmstadt, Germany; results first posted 2012-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EXpression PRofile Endometrium Samples Study. Trials, record NCT01210144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01210144
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EXpression PRofile Endometrium Samples Study
- NCT number
- NCT01210144
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 27 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- In Vitro Fertilization
- Interventions
- Gonal -f® [r-hFSH], Ovitrelle® [r-hCG alfa], Gonadotropin-releasing hormone (GnRH) Agonist, Gonadotropin-releasing hormone (GnRH) Antagonist
- First posted
- 2010-09-28
- Last updated
- 2013-12-27
- Other registries' IDs
- eudract:2007-003938-41
- Results first posted
- 2012-11-14
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® | 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. |
| Primary | Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® | 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). |
| Secondary | Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer | 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. |
| Secondary | Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol | 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. |
| 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 | 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). |
| Secondary | Gene Expression in Participants Without Blastocyst Transfer | 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. |
| Secondary | Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer | 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). |
| Secondary | Gene Expression in Participants With Good or Poor Response to Gonal-f® | 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. |
| Secondary | Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f® | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® | 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. | ||
| PRIMARY | Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® | 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. | participants | NUMBER |
| SECONDARY | Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® | 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. | ||
| SECONDARY | Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® | 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. | ||
| 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 | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® | 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. | participants | NUMBER |
| SECONDARY | Gene Expression in Participants Without Blastocyst Transfer | Day 5 or 6 (window of implantation) after Oocyte Retrieval | 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. | ||
| SECONDARY | Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer | Day 5 or 6 (window of implantation) after Oocyte Retrieval | 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. | participants | NUMBER |
| SECONDARY | Gene Expression in Participants With Good or Poor Response to Gonal-f® | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® | 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. | ||
| SECONDARY | Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f® | Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f® | 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. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® | Gonal-f® + Ovitrelle® | Proliferative phase | 2 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® | Gonal-f® + Ovitrelle® | Early secretory phase | 15 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® | Gonal-f® + Ovitrelle® | Intermediate secretory phase | 6 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | Proliferative phase | 1 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | Proliferative phase | 1 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | Early secretory phase | 8 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | Early secretory phase | 7 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | Intermediate secretory phase | 3 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | Intermediate secretory phase | 3 | participants | |
| Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | Proliferative phase | 0 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 13 | |
| Overall Study | STARTED | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 11 | |
| Overall Study | COMPLETED | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 10 | |
| Overall Study | COMPLETED | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 11 | |
| Overall Study | NOT COMPLETED | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 3 | |
| Overall Study | NOT COMPLETED | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 1 | 13 | |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 0 | 11 | |
| other | Pelvic pain | Reproductive system and breast disorders | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 0 | 13 | |
| other | Pelvic pain | Reproductive system and breast disorders | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 1 | 11 | |
| other | Abdominal pain | Gastrointestinal disorders | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 1 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 0 | 11 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | ||
| Total, all-cause mortality | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | ||
| Total, other adverse events | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 2 | 13 |
| Total, other adverse events | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 1 | 11 |
| Total, serious adverse events | Gonal-f® + Ovitrelle® (Long Agonist Protocol) | 0 | 13 |
| Total, serious adverse events | Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gonal-f® + Ovitrelle® (Long Agonist Protocol) vs Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01210144
GET https://conductscience.org/api/trials/v1/NCT01210144/registered