Actively Recruiting

Phase 3
Age: 18Years - 42Years
FEMALE
ID03859921

A Randomized Double Blind Controlled Comparison of Oral Dydrogesterone as Luteal Phase Support in Natural Cycle Frozen-thawed Embryo Transfer

Led by The University of Hong Kong · Updated on 2025-06-12

716

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the live birth rate in women undergoing natural cycle frozen-thawed embryo transfer (FET) with and without oral dydrogesterone as luteal phase support. This randomized double-blinded controlled trial aims to test the hypothesis that oral dydrogesterone may increase the live birth rate in natural cycle FET. The study is conducted at the Centre of Assisted Reproduction and Embryology, The University of Hong Kong-Queen Mary Hospital. Participants will be randomly assigned to one of two groups: one receiving oral dydrogesterone 10mg three times daily and the other receiving a placebo, both starting the day after the luteinizing hormone (LH) surge or human chorionic gonadotropin (hCG) induced ovulation, for two weeks. Embryo transfer is performed on the third or sixth day after the LH surge or hCG trigger depending on embryo stage. Women are closely monitored with pelvic ultrasounds and blood tests to track ovulation and hormone levels. During the study, participants will undergo daily monitoring leading up to ovulation and embryo transfer. Pregnancy testing occurs 16 days after FET, and pregnancy outcomes are followed for analysis. Researchers measure live birth rate as the primary outcome and also track clinical pregnancy rate, ongoing pregnancy rate, and pregnancy loss. The study includes detailed monitoring and follow-up over several weeks post-transfer to assess the effects of the treatment.

CONDITIONS

Brief Title

Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET

Who Can Participate

Age: 18Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women younger than 43 years at time of stimulated IVF
  • Undergoing frozen-thawed embryo transfer with early cleavage embryos or blastocysts after thawing
Not Eligible

You will not qualify if you...

  • Requiring hormonal replacement cycles
  • Using donor oocytes or embryos
  • Undergoing preimplantation genetic testing
  • Having untreated hydrosalpinx prior to FET
  • Refusing to join the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 2 weeks

Participants receive oral dydrogesterone or placebo starting one day after the LH surge or hCG trigger for two weeks as luteal phase support during the frozen-thawed embryo transfer cycle.

Daily medication for 2 weeks, embryo transfer occurs 3 to 7 days after LH surge or hCG trigger depending on embryo type

Follow-up

Duration - Up to 10 months after recruitment

Participants undergo a urine pregnancy test 16 days after the frozen-thawed embryo transfer and pregnancy outcomes are monitored.

1 pregnancy test visit and ongoing pregnancy follow-up visits as needed

Trial Site Locations

Total: 1 location

1

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

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Research Team

E

Ernest HY Ng, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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