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Insemination in patients with polycystic ovary syndrome: gestation rates using two stimulation patterns: letrozole vs gonadotropins.
EU CTIS ID: 2023-503477-38-00
What this study is testing
The main objective of the research study is to know if letrozole is a therapeutic alternative to gonadotropins in artificial inseminations in patients with polycystic ovary in terms of gestation rate and live birth rate.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: women between 18-40 years old.
- Body mass index (BMI): ≥18 and ≤30.
- Primary or secondary infertility.
- Diagnosis of PCOS according to Rotterdam criteria (The Rotterdam ESHRE/ASRM- sponsored PCOS Consensus Workshop Group Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod 2004; 19: 41-47).
- Insemination indication.
- Women giving informed consent to participate in the study.
You likely can't join if
- Women with BMI <18 or >30.
- Presence of any systemic disease or poorly controlled endocrinological pathology that may interfere with the objectives of the study.
- Verification by vaginal ultrasound of the presence of any residual follicle or corpus luteum.
- Patients who have not responded to letrozole in ovulation induction cycles.
- Contraindication to the use of any of the treatments foreseen by the study in the terms established in the protocol.
- Women in in vitro fertilization program.
See the full eligibility criteria
- Age: women between 18-40 years old.
- Body mass index (BMI): ≥18 and ≤30.
- Primary or secondary infertility.
- Diagnosis of PCOS according to Rotterdam criteria (The Rotterdam ESHRE/ASRM- sponsored PCOS Consensus Workshop Group Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod 2004; 19: 41-47).
- Insemination indication.
- Women giving informed consent to participate in the study.
- Women with BMI <18 or >30.
- Presence of any systemic disease or poorly controlled endocrinological pathology that may interfere with the objectives of the study.
- Verification by vaginal ultrasound of the presence of any residual follicle or corpus luteum.
- Patients who have not responded to letrozole in ovulation induction cycles.
- Contraindication to the use of any of the treatments foreseen by the study in the terms established in the protocol.
- Women in in vitro fertilization program.
- Presence of uterine malformations.
- Presence of polymyomatous uterus, with the exception of subserosal or intramural myomas <5cm that do not deform the uterine cavity.
- Moderate and severe endometriosis.
- History or presence of Pelvic Inflammatory Disease.
- Interventions on cervix that may have originated a stenosis and/or cervical stenosis at the beginning of the study.
- Unexcised or occluded hydrosalpinx.
- Existence of severe male factor: cryptozoospermia or oligoasthenoteratozoospermia or with low REM (< 5 million).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.