Comparing two IVF protocols for women with low prognosis
Impact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies
This study is testing two different IVF methods to see which one helps women with low chances of getting pregnant achieve better pregnancy rates.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Tu Du Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT04531644 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the cumulative ongoing pregnancy rates between two different in vitro fertilization (IVF) protocols in women with low prognosis for assisted reproductive techniques (ART). Participants will be divided into two groups: one receiving a double ovarian stimulation protocol (DuoStim) and the other receiving a conventional antagonist protocol. The DuoStim group will undergo two phases of stimulation with oocyte retrieval and embryo cryopreservation, while the control group will follow a standard protocol with potential fresh embryo transfer. The goal is to determine which method yields better pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 or younger with specific ovarian reserve markers and a normal uterine shape.
Not a fit: Patients with conditions like endometriosis or Asherman's syndrome, or those who have undergone certain surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pregnancy rates for women with low prognosis undergoing IVF.
How similar studies have performed: Other studies have shown promising results with similar double stimulation approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≤ 40. * AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml. * OR 3 ≤ AFC ≤7. * Normal shape of uterus (based on ultrasound). * Body mass index within 28 - 37 kg/m2 Exclusion Criteria: * Asherman's syndrome. * Endometriosis. * Leiomyomas distorting the endometrium * Sperm extracted from surgical procedures (i.e. PESA, TESE). * Patients refuse to continue participating in the study. * Patients injected with wrong dose of gonadotropins during the treatment. * Serious complications or accidents arise forcing the patients to discontinue the treatments. * Ovarian surgery * Previous chemotherapy or pelvic irradiation
Where this trial is running
Ho Chi Minh City
- Department of Infertility of Tu Du hospital — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Study coordinator: Chau TM Le, PhD
- Email: dr.lethiminhchau@gmail.com
- Phone: +84908429006
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.