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

I

Instituto Bernabeu

Status and phase

Completed
Phase 4

Conditions

Ovarian Stimulation

Treatments

Drug: Time of administration of Corifollitropin Alfa

Study type

Interventional

Funder types

Other

Identifiers

NCT03939403
IB-0319-002

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

Female

Ages

18 to 32 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

7-days pill free interval
Experimental group
Treatment:
Drug: Time of administration of Corifollitropin Alfa
5-days pill free interval
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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