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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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IVF

Intervention / Treatment
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* Drug: Progesterone 200 MG
* Drug: Ganirelix Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CONTROL GROUP<br>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. | Drug: Ganirelix Acetate<br>* The patients in the control group will administer subcutaneaous injections of ganirelix from day 5-6 of stimulation as per currently used protocol.<br>|
| Experimental: STUDY GROUP<br>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. | Drug: Progesterone 200 MG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MII oocytes | number of mature (MII) oocytes in both stimulations. | Egg collection day (between 8 and 14 days after starting of ovarian stimulation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration | duration of ovarian stimulation under both protocols. | Egg collection day (between 8 and 14 days after starting of ovarian stimulation) |