Trial · NCT03564509
A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.
NCT03564509, Phase 2, Completed, Ferring Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation. Trials, record NCT03564509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03564509
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.
- NCT number
- NCT03564509
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 620 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Controlled Ovarian Stimulation
- Interventions
FE 999302 (1 μg) and follitropin delta, FE 999302 (2 μg) and follitropin delta, FE 999302 (4 μg) and follitropin delta, FE 999302 (8 μg) and follitropin delta, FE 999302 (12 μg) and follitropin delta, Placebo and follitropin delta
- First posted
- 2018-06-21
- Last updated
- 2023-08-31
- Other registries' IDs
- eudract:2017-003810-13
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of good-quality blastocysts on Day 5 after oocyte retrieval | On Day 5 after oocyte retrieval | Quality of blastocysts was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell). |
| Secondary | Number of subjects with at least one good-quality blastocyst on Day 5 after oocyte retrieval | On Day 5 after oocyte retrieval | Quality of blastocysts was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell). |
| Secondary | Number of subjects with at least two good-quality blastocysts on Day 5 after oocyte retrieval | On Day 5 after oocyte retrieval | Quality of blastocysts was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell). |
| Secondary | Number and quality of embryos on Day 3 after oocyte retrieval | On Day 3 after oocyte retrieval | Embryo quality was assessed by cleavage stage and embryo morphology parameters. The total number of embryos and the number of embryos per quality category were reported. |
| Secondary | Number and quality of blastocysts on Day 5 after oocyte retrieval | On Day 5 after oocyte retrieval | Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells). The total number of blastocysts and the number of blastocysts per quality category will be reported. |
| Secondary | Changes in serum hormone levels | Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval | Blood samples for analysis of hormone concentrations were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, last day of stimulation, and at oocyte retrieval. |
| Secondary | Number and size of follicles on stimulation Day 6 | On stimulation Day 6 | Number and size of follicles assessed using transvaginal ultrasound. The total number of follicles and the number of follicles per size category were reported. |
| Secondary | Number and size of follicles at end-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Number and size of follicles assessed using transvaginal ultrasound. The total number of follicles and the number of follicles per size category were reported. |
| Secondary | Positive beta human chorionic gonadotropin (βhCG) rate | 13-15 days after blastocyst transfer | Proportion of patients with positive blood βhCG confirmed by a blood test. |
| Secondary | Clinical pregnancy rate | 5-6 weeks after blastocyst transfer | Clinical pregnancy was defined as at least one gestational sac, either intrauterine or ectopic. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37194068 | RESULT |
Source PubMed
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/NCT03564509
GET https://conductscience.org/api/trials/v1/NCT03564509/registered?page=2