Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor

NCT03939403 | Completed Phase 4

• 1 other identifier: IB-0319-002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of hormonal contraceptive and supplementation with follicle-stimulating hormone daily administration from the 8th day of stimulation). This a controlled randomized clinical study and 180 patients will be recruited (90 per arm) and the primary study outcome is the number of obtained oocytes.

Conditions

Ovarian Stimulation

Outcome Measures

Primary Outcomes (1)

• Number of oocytes

  Number of oocytes after stimulation

  At the end of stimulation

Study Arms (2)

7-days pill free interval

EXPERIMENTAL

Drug: Time of administration of Corifollitropin Alfa

5-days pill free interval

NO INTERVENTION

Interventions

Time of administration of Corifollitropin Alfa DRUG

The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity. The control grup will receive the treatment on the 5th day after the cessation of hormonal contraceptive use. The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity. The intervention grup will receive the treatment on the 7th day after the cessation of hormonal contraceptive use.

7-days pill free interval

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible for oocyte donation program
• Age between 18 and 32 years old
• BMI \>18 and \<30
• Antral follicle count \>12 (summing both ovaries)
• Presence of both ovaries
• Ability to participate in and comply with study protocol
• Signed informed consent
• No treatment with ovulation stimulators in the 3 months prior to the start of stimulation.

You may not qualify if:

• Diagnosis of endometriosis at any stage
• AFC \>20
• Polycystic ovary syndrome
• Concurrent participation in another study

Sponsors & Collaborators

• Instituto Bernabeu: lead

Study Sites (1)

Instituto Bernabeu

Alicante, 03016, Spain

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 6, 2019
• Study Start: November 18, 2019
• Primary Completion: May 8, 2021
• Study Completion: May 8, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

ES (1)