Last reviewed · How we verify
Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696)
Phase 4 trial testing Marvelon in Infertility in 442 participants. Completed in 24 July 2008.
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 442 |
| Start date | 1 October 2006 |
| Primary completion | 24 July 2008 |
| Estimated completion | 24 July 2008 |
Organon and Co — full company profile →
Adults 18 to 39, female only, with Infertility. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response
| Group | Value | 95% CI |
|---|---|---|
| Oral Contraceptive | 12.4 | ± 6.7 |
| Non-Oral Contraceptive | 12.1 | ± 7.7 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Oral Contraceptive | Non-Oral Contraceptive |
|---|---|---|---|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | — | — |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | — | — |
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | — | — |
| Colitis ulcerative | Gastrointestinal disorders | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | — | — |
| Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | — | — |
| Retroplacental haematoma | Pregnancy, puerperium and perinatal conditions | — | — |
| Ovarian cyst | Reproductive system and breast disorders | — | — |
| Ovarian cyst ruptured | Reproductive system and breast disorders | — | — |
| Abortion induced | Surgical and medical procedures | — | — |
| Reaction | System | Oral Contraceptive | Non-Oral Contraceptive |
|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | — | — |
| Pelvic discomfort | Reproductive system and breast disorders | — | — |
| Pelvic pain | Reproductive system and breast disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | — | — |
| Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | — | — |
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | — | — |
Most-reported serious reactions: Ovarian hyperstimulation syndrome, Ectopic pregnancy, Ruptured ectopic pregnancy, Colitis ulcerative, Pancreatitis, Abortion spontaneous, Antepartum haemorrhage, Retroplacental haematoma.
Data from ClinicalTrials.gov NCT00778999 adverse events section.
The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation to provide adequate numbers of good quality oocytes and embryos. This optimization is mainly valuable to a group of infertility patients (9%-24%) who respond poorly to Controlled Ovarian Stimulation(COS). It is also important for an additional 2.6% of the infertility patients who manifest a high response to gonadotropin and are at risk for hyperstimulation syndrome, a life-threatening situation. Extensive research was carried out and led to the introduction of GnRH antagonist, as an alternative to Gonadotropin Releasing Hormone (GnRH) agonist, for the prevention of premature Luteinizing Hormone (LH) surges. Further research to optimize the GnRH antagonist regimen concluded that a daily treatment with 200 IU of recombinant Follicle Stimulating Hormone (recFSH) in a GnRH antagonist regimen is safe, well tolerated and results in a good clinical outcome. This protocol is now frequently applied in the US and Europe. Predicting a woman's response (based on the assessment of ovarian reserve) to COS is useful in determining individualized clinical management strategies for low and high responders and thus avoiding cancellation. Such prediction when based on reliable scientific evidence is valuable in consulting patients about their chances of success. A large number of studies have been performed, which used certain clinical, ultrasonographic and hormonal markers (called predictive factors), to try to optimize a COS protocol for patients who were down-regulated with a long GnRH agonist protocol. Prospective trials of predictive models have also been used to adjust the starting dose of FSH to prevent a too low or too high ovarian response. To date, however, none have been performed for women undergoing ovarian stimulation with a GnRH antagonist protocol. The primary objective of this randomized, open-label, multicenter clinical trial was to identify one or more factors capable of predicting ovarian response in women treated with a daily dose of 200 IU recFSH in a GnRH antagonist protocol. Since many ART centers now use oral contraceptives as a means to schedule patients stimulated with recFSH and a GnRH antagonist for assisted reproduction, the trial evaluated also whether intervention with oral contraceptives affects the accuracy of predictive models for ovarian response.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00778999.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing