Trial · NCT04778358
Higher Dose of Rekovelle in Oocyte Donors
NCT04778358, Phase 2, Completed, IVI Madrid
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Higher Dose of Rekovelle in Oocyte Donors. Trials, record NCT04778358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04778358
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Higher Dose of Rekovelle in Oocyte Donors
- NCT number
- NCT04778358
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- IVI Madrid
- Conditions
- IVF
- Interventions
- Follitropin Delta, Recombinant
- First posted
- 2021-03-03
- Last updated
- 2022-11-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25). | Number of oocytes obtained inmediatly after the ovarian puncture in visit 5 | To evaluate the number of oocytes of a fixed dose of 15µg of the drug Rekovelle (follitropin delta) during the entire stimulation of oocyte donors aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25). |
| Primary | Measure the incidence of ovarian hyperstimulation syndrome using15µg of follitropin delta aimed at obtaining 17 oocytes | Through the study completion, an average 1 month. | Evaluate with a GOLAN scale. Golan classification: Classify early or late ovarian hyperstimulation syndrome, according to clinic, ultrasound and laboratory tests Mild ovarian hyperstimulation: * Grade 1 Abdominal discomfort and bloating * Grade 2 Grade 1 + nausea, vomiting, or diarrhea. Ovaries enlarged 5-12 cm in ø Moderate Hyperstimulation: • Grade 3 Grade 2 + ultrasound signs of ascites Severe hyperstimulation: * Grade 4 Grade 3 + clinical ascites, respiratory distress, hydrothorax * Grade 5 Grade 4 and hemoconcentration, hypovolemia, impaired coagulation and renal function (oligo / anuria) |
| Secondary | Number of mature oocytes | Number of madure oocytes obtained inmediatly after the puncture in visit 5 | Evaluate the number of mature oocyte |
| Secondary | Duration of stimulation in days | Number of days during the ovarian stimulation up to 20 days | Evaluate the duration of stimulation in days |
| Secondary | Number of blasts | 4-6 days after fertilization and before implantation in the endometrium during the treatment. | Early stage of embryonic development that appears 4-6 days after fertilization and before implantation in the endometrium |
| Secondary | Blast quality | 4-6 days after fertilization and before implantation in the endometrium during the treatment. | Blast quality according to the Gardner scale, classification of blastocysts, where in addition to the structure of the inner cell mass (ICM) and cells of the trophectoderm, it provides a degree of expansion |
| Secondary | Degree of satisfaction with the infertility treatment | At the end of the treatment, an average 1 month. | Degree of satisfaction with the infertility treatment according to the EFESO, Questionnaire designed to know the degree of satisfaction of women who undergo ovarian stimulation treatment to treat their infertility questionnaire |
Source ClinicalTrials.gov
Outcomes0
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/NCT04778358
GET https://conductscience.org/api/trials/v1/NCT04778358/registered