Trial · NCT01185704
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
NCT01185704, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2013-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART). Trials, record NCT01185704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01185704
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
- NCT number
- NCT01185704
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 136 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Polycystic Ovarian Syndrome
- Interventions
- Cetrorelix acetate, Cetrorelix acetate, Recombinant Human Choriogonadotropin (r-hCG), Recombinant human follicle stimulating hormone (r-hFSH)
- First posted
- 2010-08-20
- Last updated
- 2014-02-13
- Other registries' IDs
- eudract:2007-007932-25
- Results first posted
- 2013-07-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estradiol (E2) Levels on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 15 days]) | |
| Secondary | Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels | Day 1 | |
| Secondary | Serum Estradiol (E2) Levels | Day 1 | |
| Secondary | Serum Progesterone (P4) Levels | Day 1 | |
| Secondary | Anti Mullerian Hormone (AMH) Levels | Day 0 | |
| Secondary | Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 15 days]) | |
| Secondary | Number and Quality of Oocytes Retrieved | Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]) | Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes. |
| Secondary | Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) | Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days]) | |
| Secondary | Percentage of Fertilized Oocytes Retrieved | Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]) | Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope. |
| Secondary | Number of Embryos | Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]) | Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Estradiol (E2) Levels on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 15 days]) | Intent to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | picogram/milliliter (pg/mL) | MEAN |
| SECONDARY | Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels | Day 1 | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Here n signifies those participants who were evaluated for specified category. | International unit/liter (IU/L) | MEAN |
| SECONDARY | Serum Estradiol (E2) Levels | Day 1 | ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | pg/mL | MEAN |
| SECONDARY | Serum Progesterone (P4) Levels | Day 1 | ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | nanomolar/liter (nmol/L) | MEAN |
| SECONDARY | Anti Mullerian Hormone (AMH) Levels | Day 0 | ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | nanogram/milliliter (ng/mL) | MEAN |
| SECONDARY | Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 15 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | follicles | MEAN |
| SECONDARY | Number and Quality of Oocytes Retrieved | Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | oocytes | MEAN |
| SECONDARY | Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) | Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | international unit (IU) | MEAN |
| SECONDARY | Percentage of Fertilized Oocytes Retrieved | Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | percent fertilized oocytes | MEAN |
| SECONDARY | Number of Embryos | Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | embryos | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Estradiol (E2) Levels on r-hCG Day | Day 1 Protocol | 1668.86 | Standard Deviation 862.62 | picogram/milliliter (pg/mL) | |
| Estradiol (E2) Levels on r-hCG Day | Day 7 Protocol | 1672.80 | Standard Deviation 835.49 | picogram/milliliter (pg/mL) | |
| Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels | Day 1 Protocol | LH levels (n=58, 62) | 4.87 | Standard Deviation 4.62 | International unit/liter (IU/L) |
| Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels | Day 7 Protocol | LH levels (n=58, 62) | 6.84 | Standard Deviation 3.99 | International unit/liter (IU/L) |
| Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels | Day 1 Protocol | FSH levels (n=57, 59) | 4.98 | Standard Deviation 1.54 | International unit/liter (IU/L) |
| Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels | Day 7 Protocol | FSH levels (n=57, 59) | 6.69 | Standard Deviation 10.29 | International unit/liter (IU/L) |
| Serum Estradiol (E2) Levels | Day 1 Protocol | 30.42 | Standard Deviation 14.06 | pg/mL | |
| Serum Estradiol (E2) Levels | Day 7 Protocol | 68.79 | Standard Deviation 116.09 | pg/mL | |
| Serum Progesterone (P4) Levels | Day 1 Protocol | 0.83 | Standard Deviation 0.72 | nanomolar/liter (nmol/L) | |
| Serum Progesterone (P4) Levels | Day 7 Protocol | 0.97 | Standard Deviation 1.82 | nanomolar/liter (nmol/L) |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Day 1 Protocol | 68 | |
| Overall Study | STARTED | Day 7 Protocol | 68 | |
| Overall Study | Treated | Day 1 Protocol | 65 | |
| Overall Study | Treated | Day 7 Protocol | 65 | |
| Overall Study | COMPLETED | Day 1 Protocol | 55 | |
| Overall Study | COMPLETED | Day 7 Protocol | 60 | |
| Overall Study | NOT COMPLETED | Day 1 Protocol | 13 | |
| Overall Study | NOT COMPLETED | Day 7 Protocol | 8 |
Source ClinicalTrials.gov
Adverse events36
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 | Abdominal pain | Gastrointestinal disorders | Day 1 Protocol | 0 | 65 | |
| other | Abdominal pain | Gastrointestinal disorders | Day 7 Protocol | 1 | 65 | |
| other | Anal fissure | Gastrointestinal disorders | Day 1 Protocol | 1 | 65 | |
| other | Anal fissure | Gastrointestinal disorders | Day 7 Protocol | 0 | 65 | |
| other | Nausea | Gastrointestinal disorders | Day 1 Protocol | 2 | 65 | |
| other | Nausea | Gastrointestinal disorders | Day 7 Protocol | 1 | 65 | |
| other | Headache | Nervous system disorders | Day 1 Protocol | 6 | 65 | |
| other | Headache | Nervous system disorders | Day 7 Protocol | 1 | 65 | |
| other | Injection site erythema | General disorders | Day 1 Protocol | 1 | 65 | |
| other | Injection site erythema | General disorders | Day 7 Protocol | 1 | 65 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Day 1 Protocol | ||
| Total, all-cause mortality | Day 7 Protocol | ||
| Total, other adverse events | Day 1 Protocol | 9 | 65 |
| Total, other adverse events | Day 7 Protocol | 14 | 65 |
| Total, serious adverse events | Day 1 Protocol | 2 | 65 |
| Total, serious adverse events | Day 7 Protocol | 4 | 65 |
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 |
|---|
| Day 1 Protocol vs Day 7 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/NCT01185704
GET https://conductscience.org/api/trials/v1/NCT01185704/results?page=2