DRUG
Progesterone 200 MG
The patients in the study group will administer oral natural micronized progesterone capsules from day 1 of ovarian stimulation instead of "antagonist" (ganirelix) subcutaneaous injections from day 5-6 of stimulation.
Status
Completed
Phase
Phase 4
Enrollment
150
Locations
1
Results
Not posted
Publications
12
Study 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.
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.
Interventions
DRUG
The patients in the study group will administer oral natural micronized progesterone capsules from day 1 of ovarian stimulation instead of "antagonist" (ganirelix) subcutaneaous injections from day 5-6 of stimulation.
DRUG
The patients in the control group will administer subcutaneaous injections of ganirelix from day 5-6 of stimulation as per currently used protocol.
Timeline
First posted
Jul 20, 2023
Study start
Dec 23, 2023
Primary completion
Apr 3, 2025
Study completion
Aug 30, 2025
Results posted
Not reported
Registry updated
Mar 27, 2026
Outcomes
MII oocytes
Time frame · Egg collection day (between 8 and 14 days after starting of ovarian stimulation)
number of mature (MII) oocytes in both stimulations.
Duration
Time frame · Egg collection day (between 8 and 14 days after starting of ovarian stimulation)
duration of ovarian stimulation under both protocols.
Eligibility
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 locations
Spain. Showing up to 24 locations stored in the fast local snapshot.
Instituto Bernabeu
Elche, Alicante, Spain
Publications
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