Comparing natural progesterone and GnRH antagonist for preventing LH peak during IVF.
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.
This study is testing if a natural progesterone pill works as well as an injection to prevent hormone spikes during IVF for women trying to get pregnant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 33 Years |
| Sex | Female |
| Sponsor | Instituto Bernabeu Academic / other |
| Locations | 1 site (Elche, Alicante) |
| Trial ID | NCT05954962 on ClinicalTrials.gov |
What this trial studies
This study investigates whether oral micronized natural progesterone is as effective as a subcutaneous GnRH antagonist in preventing the LH peak during controlled ovarian stimulation in women undergoing IVF. It will involve 150 women, randomly assigned to receive either progesterone or the antagonist, with the primary outcome being the number of mature oocytes retrieved. The study is designed as a prospective, controlled, single-center trial and aims to provide insights into optimizing ovarian stimulation protocols.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 33 who are eligible for the oocyte donation program and meet specific health criteria.
Not a fit: Patients with endometriosis, ovarian tumors, or those who have irregular periods may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective and potentially less invasive option for women undergoing IVF.
How similar studies have performed: Other studies have explored similar hormonal interventions in IVF, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Elche, Alicante
- Instituto Bernabeu — Elche, Alicante, Spain (Recruiting)
Study contacts
- Study coordinator: Anna Pitas, PhD
- Email: apitas@institutobernabeu.com
- Phone: +34663926079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.