Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET
A Randomized Double Blind Controlled Comparison of Oral Dydrogesterone as Luteal Phase Support in Natural Cycle Frozen-thawed Embryo Transfer
1 other identifier
interventional
716
1 country
1
Brief Summary
This randomised double-blinded controlled trial aims to compare the live birth rate in natural FET cycles with and without oral dydrogesterone as luteal phase support. The hypothesis is that the use of oral dydrogesterone will increase the live birth rate of natural cycle FET.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2021
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
ExpectedJune 12, 2025
March 1, 2025
4.5 years
February 26, 2019
June 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
live birth rate
the number of live birth beyond 22 weeks gestation per transfer cycle
10 months after recruitment
Secondary Outcomes (3)
Clinical pregnancy rate
6 weeks of gestation after recruitment
Ongoing pregnancy rate
10 weeks of gestation after recruitment
Pregnancy loss per number of transfer cycles
less than 22 weeks of gestation
Study Arms (2)
Dydrogesterone group
EXPERIMENTALOral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation.
Placebo group
PLACEBO COMPARATORPlacebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation.
Interventions
Eligibility Criteria
You may qualify if:
- Age of women \<43 years at the time of stimulated IVF
- Replacing early cleavage embryos or blastocysts after thawing
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernest HY Ng, MD
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2019
First Posted
March 1, 2019
Study Start
July 1, 2021
Primary Completion
December 30, 2025
Study Completion (Estimated)
November 30, 2026
Last Updated
June 12, 2025
Record last verified: 2025-03