Efficacy of Micronized Natural Progesterone Vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.

Phase 4

Recruiting

• Conditions: IVF
• Interventions: Drug: Ganirelix Acetate; Drug: Progesterone 200 MG

• Registration Number: NCT05954962
• Lead Sponsor: Instituto Bernabeu

Brief Summary

This study aims to investigate if the use of oral micronized natural progesterone is not inferior to the use of subcutaneous antagonist in preventing LH peak in controlled ovarian stimulation.

Detailed Description

The study will aim to include 150 women (egg donors): 75 per group and the principal variable will be the number of retrieved mature (MII) oocytes. Randomized, prospective, controlled, single center, phase IV study.

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Study Start: 2023-12-23
• Status Verified: 2024-11
• Primary Completion: 2024-12-30
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Eligibility for the oocyte donation program at Instituto Bernabeu.
• Age between 18 and 33 years
• BMI >18 and <30
• Overall antral follicle count >8
• Presence of both ovaries
• Ability to participate and comply with the study protocol
• Oral and written comprehension of Spanish
• Having given written consent

Exclusion Criteria

• Endometriosis at any stage
• Any ovarian tumor whether benign or malignant
• Concurrent participation in another study
• Malabsorptive syndromes that may alter the efficacy of Seidigestan ® such as bariatric surgery, ulcerative colitis or Crohn's disease
• Irregular periods
• Hypogonadotropic hypogonadism
• Having received in the previous two months treatment with ovulation stimulators
• Having previously participated in the present study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL GROUP	Ganirelix Acetate	The patient will start to administer: (1) daily subcutaneous injections of gonadotropins on day 1 of ovarian stimulation (2) daily subcutenous injections of ganirelix ("antagonist") on day 5 or 6 of ovarian stimulation. Both medication will be stopped 1-2 days before egg retrieval.
STUDY GROUP	Progesterone 200 MG	The patient will start to administer: (1) daily subcutaneous injections of gonadotropins on day 1 of ovarian stimulation (2) daily oral capsules of natural micronized progesterone on day 1 of ovarian stimulation. Both medication will be stopped 1-2 days before egg retrieval.

Primary Outcome Measures

Name	Time	Method
MII oocytes	Egg collection day (between 8 and 14 days after starting of ovarian stimulation)	number of mature (MII) oocytes in both stimulations.

Secondary Outcome Measures

Name	Time	Method
Duration	Egg collection day (between 8 and 14 days after starting of ovarian stimulation)	duration of ovarian stimulation under both protocols.

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Elche, Alicante, Spain