Trial · NCT05263388
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
NCT05263388, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2025-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation. Trials, record NCT05263388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05263388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
- NCT number
- NCT05263388
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 302 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Infertility
- Interventions
- REKOVELLE (Follitropin Delta), GONAL-F (Follitropin Alfa)
- First posted
- 2022-03-02
- Last updated
- 2025-04-02
- Results first posted
- 2025-04-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved | On day of oocyte retrieval (Up to 22 days after start of stimulation) | The number of oocytes retrieved was recorded at the oocyte retrieval visit. |
| Secondary | Number of Follicles (Total) at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Counted by transvaginal ultrasound for the right and left ovary for each subject. |
| Secondary | Size of the Follicles at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Counted by ultrasound for the right and left ovary for each subject. |
| Secondary | Serum Concentrations of Estradiol at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Blood samples for analysis of circulating concentrations of estradiol were drawn. |
| Secondary | Serum Concentrations of Progesterone at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Blood samples for analysis of circulating concentrations of progesterone were drawn. |
| Secondary | Number of Fertilized Oocytes | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | The number of pronuclei were counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) were regarded as correctly fertilized. |
| Secondary | Fertilization Rate | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved. |
| Secondary | Number of Blastocysts and Number of Good Quality Blastocysts | On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation) | Number of blastocysts and number of good quality blastocysts on Day 5 or 6 were presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner \& Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher. |
| Secondary | Total Gonadotropin Dose | Up to 20 stimulation days | Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP). |
| Secondary | Number of Stimulation Days | Up to 20 stimulation days | Calculated by start dates and end dates. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Oocytes Retrieved | On day of oocyte retrieval (Up to 22 days after start of stimulation) | Oocytes Retrieved | MEDIAN | |
| SECONDARY | Number of Follicles (Total) at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | Follicles | MEDIAN | |
| SECONDARY | Size of the Follicles at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | mm | MEDIAN | |
| SECONDARY | Serum Concentrations of Estradiol at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | pmol/L | MEDIAN | |
| SECONDARY | Serum Concentrations of Progesterone at End-of-stimulation | At end-of-stimulation (up to 20 stimulation days) | nmol/L | MEDIAN | |
| SECONDARY | Number of Fertilized Oocytes | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | Oocytes | MEDIAN | |
| SECONDARY | Fertilization Rate | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | percentage of oocytes fertilised | MEDIAN | |
| SECONDARY | Number of Blastocysts and Number of Good Quality Blastocysts | On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation) | Blastocysts | MEDIAN | |
| SECONDARY | Total Gonadotropin Dose | Up to 20 stimulation days | ug | MEDIAN | |
| SECONDARY | Number of Stimulation Days | Up to 20 stimulation days | days | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Oocytes Retrieved | REKOVELLE (Follitropin Delta) | 9.0 | Inter-Quartile Range 6.0 to 13.5 | Oocytes Retrieved | |
| Number of Oocytes Retrieved | GONAL-F (Follitropin Alfa) | 9.0 | Inter-Quartile Range 6.5 to 13.0 | Oocytes Retrieved | |
| Number of Follicles (Total) at End-of-stimulation | REKOVELLE (Follitropin Delta) | 12.0 | Inter-Quartile Range 9.0 to 16.0 | Follicles | |
| Number of Follicles (Total) at End-of-stimulation | GONAL-F (Follitropin Alfa) | 12.0 | Inter-Quartile Range 9.0 to 16.0 | Follicles | |
| Size of the Follicles at End-of-stimulation | REKOVELLE (Follitropin Delta) | 15.7 | Inter-Quartile Range 14.7 to 16.8 | mm | |
| Size of the Follicles at End-of-stimulation | GONAL-F (Follitropin Alfa) | 16.0 | Inter-Quartile Range 15.1 to 16.9 | mm | |
| Serum Concentrations of Estradiol at End-of-stimulation | REKOVELLE (Follitropin Delta) | 6085.0 | Inter-Quartile Range 3516.0 to 8602.0 | pmol/L | |
| Serum Concentrations of Estradiol at End-of-stimulation | GONAL-F (Follitropin Alfa) | 5853.5 | Inter-Quartile Range 4053.5 to 9742.0 | pmol/L | |
| Serum Concentrations of Progesterone at End-of-stimulation | REKOVELLE (Follitropin Delta) | 2.9 | Inter-Quartile Range 1.9 to 3.8 | nmol/L | |
| Serum Concentrations of Progesterone at End-of-stimulation | GONAL-F (Follitropin Alfa) | 2.5 | Inter-Quartile Range 1.6 to 3.5 | nmol/L |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | REKOVELLE (Follitropin Delta) | 200 | |
| Overall Study | STARTED | GONAL-F (Follitropin Alfa) | 100 | |
| Overall Study | COMPLETED | REKOVELLE (Follitropin Delta) | 196 | |
| Overall Study | COMPLETED | GONAL-F (Follitropin Alfa) | 94 | |
| Overall Study | NOT COMPLETED | REKOVELLE (Follitropin Delta) | 4 | |
| Overall Study | NOT COMPLETED | GONAL-F (Follitropin Alfa) | 6 |
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 | Headache | Nervous system disorders | REKOVELLE (Follitropin Delta) | 23 | 200 | 27 |
| other | Headache | Nervous system disorders | GONAL-F (Follitropin Alfa) | 8 | 100 | 12 |
| other | Pelvic pain | Reproductive system and breast disorders | REKOVELLE (Follitropin Delta) | 1 | 200 | 1 |
| other | Pelvic pain | Reproductive system and breast disorders | GONAL-F (Follitropin Alfa) | 5 | 100 | 5 |
| serious | Haemoperitoneum | Gastrointestinal disorders | REKOVELLE (Follitropin Delta) | 0 | 200 | 0 |
| serious | Haemoperitoneum | Gastrointestinal disorders | GONAL-F (Follitropin Alfa) | 2 | 100 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | REKOVELLE (Follitropin Delta) | 0 | 200 |
| Total, all-cause mortality | GONAL-F (Follitropin Alfa) | 0 | 100 |
| Total, other adverse events | REKOVELLE (Follitropin Delta) | 24 | 200 |
| Total, other adverse events | GONAL-F (Follitropin Alfa) | 11 | 100 |
| Total, serious adverse events | REKOVELLE (Follitropin Delta) | 0 | 200 |
| Total, serious adverse events | GONAL-F (Follitropin Alfa) | 2 | 100 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40633120 | DERIVED |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| REKOVELLE (Follitropin Delta) vs GONAL-F (Follitropin Alfa): deaths from any cause | Trial comparisons |
| REKOVELLE (Follitropin Delta) vs GONAL-F (Follitropin Alfa): serious adverse events | 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/NCT05263388
GET https://conductscience.org/api/trials/v1/NCT05263388/results?page=2