IVF
Conditions
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.
Interventions
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.
The patients in the control group will administer subcutaneaous injections of ganirelix from day 5-6 of stimulation as per currently used protocol.
Sponsors
Instituto Bernabeu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 33 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MII oocytes | Egg collection day (between 8 and 14 days after starting of ovarian stimulation) | number of mature (MII) oocytes in both stimulations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration | Egg collection day (between 8 and 14 days after starting of ovarian stimulation) | duration of ovarian stimulation under both protocols. |
Countries
Spain
Outcome results
None listed