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

Instituto Bernabeu

Status and phase: Enrolling; Phase 4

Conditions: IVF

Treatments: Drug: Ganirelix Acetate; Drug: Progesterone 200 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05954962

IBMR43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 33 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

CONTROL GROUP

Active Comparator group

Description:

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.

Treatment:

Drug: Ganirelix Acetate

STUDY GROUP

Experimental group

Description:

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.

Treatment:

Drug: Progesterone 200 MG