Comparing different doses and methods of progesterone for improving endometrial receptivity
Exploratory Study on the Impact of Different Doses and Route of Administration of Exogenous Progesterone in Artificial Endometrial Preparation Cycles on Endometrial Structure and Function
This study is testing different ways and amounts of progesterone to see which one helps women get their bodies ready for embryo transfer during fertility treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT04499131 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the optimal dose and route of administration of exogenous progesterone to enhance endometrial receptivity in women undergoing artificial endometrial preparation cycles for embryo transfer. It will compare the effects of vaginal, subcutaneous, and intramuscular progesterone on endometrial function and structure, as well as serum progesterone levels. The outcomes will be assessed against a control group consisting of natural cycles without exogenous progesterone. The goal is to identify the most effective approach to improve fertility outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women aged 18-35 with regular menstrual cycles and no history of infertility.
Not a fit: Patients with uterine or adnexal pathologies, or those with a history of thrombosis or breast cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fertility treatment protocols for women undergoing assisted reproductive technologies.
How similar studies have performed: While there have been studies on progesterone administration, this specific comparison of doses and routes in artificial cycles is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria All women with no history of infertility who agree to participate in the study: 1. Age: 18-35 years old, both inclusive 2. Regular menstrual cycles 3. In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study. Exclusion Criteria Subjects who meet one or more of the following will not be considered eligible to participate in the pilot study: 1. Simultaneous participation in other clinical studies that, at the researcher's criteria, could interfere with the results of this study. 2. Taking oral contraceptives in the three months prior to signing informed consent. 3. Presence of uterine pathology (submucosal or intramural myomas \>4 cm deforming cavity, endometrial polyps or müllerian anomalies) or adnexal pathology (communicating hydrosalpinx). 4. Background of thrombosis, breast cancer, systemic diseases. 5. Those unable to comprehend the investigational nature of the proposed study.
Where this trial is running
Valencia
- Instituto Valenciano de Infertilidad Spain — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Laura Caracena
- Email: Laura.Caracena@ivirma.com
- Phone: +34 963050999
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.