Using oral dydrogesterone to support pregnancy in natural cycle frozen embryo transfers
A Randomized Double Blind Controlled Comparison of Oral Dydrogesterone as Luteal Phase Support in Natural Cycle Frozen-thawed Embryo Transfer
This study is testing if taking a pill called dydrogesterone can help women under 43 who are having frozen embryo transfers have a better chance of a successful pregnancy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 716 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT03859921 on ClinicalTrials.gov |
What this trial studies
This randomized double-blinded controlled trial aims to evaluate the effectiveness of oral dydrogesterone in increasing live birth rates during natural frozen embryo transfer (FET) cycles. Women undergoing FET at the University of Hong Kong-Queen Mary Hospital will be randomly assigned to receive either oral dydrogesterone or a placebo for two weeks following ovulation. The study will monitor the outcomes of these treatments to determine if dydrogesterone provides a significant benefit in supporting pregnancy. The trial focuses on women under 43 years of age who are undergoing FET with thawed embryos.
Who should consider this trial
Good fit: Ideal candidates for this study are women under 43 years old who are undergoing frozen embryo transfer with early cleavage embryos or blastocysts.
Not a fit: Patients who require hormonal replacement cycles, use donor oocytes or embryos, or have not corrected hydrosalpinx prior to FET may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve live birth rates for women undergoing natural cycle frozen embryo transfers.
How similar studies have performed: Other studies have shown promising results with similar approaches, suggesting that dydrogesterone may enhance pregnancy outcomes in assisted reproductive technologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of women \<43 years at the time of stimulated IVF * Replacing early cleavage embryos or blastocysts after thawing Exclusion Criteria: * Requiring hormonal replacement cycles * Use of donor oocytes or embryos * Undergoing preimplantation genetic testing * Presence of hydrosalpinx not corrected surgically prior to FET * Refusal to join the study
Where this trial is running
Hong Kong, Hong Kong
- Department of Obstetrics and Gynaecology — Hong Kong, Hong Kong, China (Recruiting)
Study contacts
- Principal investigator: Ernest HY Ng, MD — The University of Hong Kong
- Study coordinator: Ernest HY Ng, MD
- Email: nghye@hku.hk
- Phone: 852-28553400
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.