Trial · NCT04773353
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women
NCT04773353, Phase 3, Completed, Ferring Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women. Trials, record NCT04773353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04773353
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women
- NCT number
- NCT04773353
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 220 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Infertility
- Interventions
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- First posted
- 2021-02-26
- Last updated
- 2025-01-24
Source ClinicalTrials.gov
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ongoing pregnancy rate | 10-11 weeks after embryo transfer | Ongoing pregnancy is defined as at least one intrauterine viable fetus 10-11 weeks after embryo transfer. |
| Secondary | Positive beta human chorionic gonadotropin (βhCG) rate | 13-15 days after embryo transfer | Positive βhCG is defined as positive serum βhCG test 13-15 days after embryo transfer. |
| Secondary | Clinical pregnancy rate | 5-6 weeks after embryo transfer | Clinical pregnancy is defined as at least one gestational sac 5-6 weeks after embryo transfer. |
| Secondary | Vital pregnancy rate | 5-6 weeks after embryo transfer | Vital pregnancy is defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after embryo transfer. |
| Secondary | Implantation rate | 5-6 weeks after embryo transfer | Implantation rate is defined as the number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred. |
| Secondary | Ongoing implantation rate | 10-11 weeks after embryo transfer | Ongoing implantation rate is defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred. |
| Secondary | Proportion of subjects with extreme ovarian responses | On day of oocyte retrieval (up to 22 days after start of stimulation) | Extreme ovarian response is defined as \<4, ≥15 or ≥20 oocytes retrieved. |
| Secondary | Proportion of subjects with early ovarian hyperstimulation syndrome (OHSS) (including OHSS of moderate/severe grade) and/or preventive interventions for early OHSS | ≤9 days after triggering of final follicular maturation | The proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS will be presented. |
| Secondary | Proportion of subjects with cycle cancellation due to poor or excessive ovarian response or embryo transfer cancellation due to excessive ovarian response / OHSS risk | At end-of-stimulation (up to 20 stimulation days) or transfer visit | The proportion of participants with cycle cancellation due to poor or excessive ovarian response or embryo transfer cancellation due to excessive ovarian response / OHSS risk will be presented. |
| Secondary | Number of follicles on stimulation Day 6 | On stimulation Day 6 | Counted by ultrasound for the right and left ovary. |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04773353
GET https://conductscience.org/api/trials/v1/NCT04773353/registered?page=2