Clinical trial NCT05954962: Efficacy of Micronized Natural Progesterone Vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.
Official title: Evaluation of the Efficacy of Micronized Natural Progesterone (Seidigestan®) Vs GnRH Antagonist (Astarté®) in the Prevention of LH Peak During Controlled Ovarian Stimulation: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: IVF
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MII oocytes
timeFrame: Egg collection day (between 8 and 14 days after starting of ovarian stimulation)
Secondary outcomes:
measure: Duration
timeFrame: Egg collection day (between 8 and 14 days after starting of ovarian stimulation)
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Instituto Bernabeu
state: Alicante
Study officials:
References:
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