Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET
ConditionSubfertility
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age of women <43 years at the time of stimulated IVF
Replacing early cleavage embryos or blastocysts after thawing
Disqualifiers
Requiring hormonal replacement cycles
Use of donor oocytes or embryos
Undergoing preimplantation genetic testing
Presence of hydrosalpinx not corrected surgically prior to FET
Trial design
Design model
Parallel
Treatments tested in this trial
Dydrogesterone
DrugProgesterone
Placebo
DrugPlacebo with appearance similar to Dydrogesterone
Treatment groups
716 Participants
are divided into 2 treatment groupsGroup A: Dydrogesterone groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
live birth rate
the number of live birth beyond 22 weeks gestation per transfer cycle
Time frame
10 months after recruitmentSecondary outcomes
1
Clinical pregnancy rate
the number of women with an intrauterine gestational sac at 5-6 weeks of gestation
Time frame
6 weeks of gestation after recruitment2
Ongoing pregnancy rate
the number of intrauterine pregnancies with fetal pulsation beyond 10 gestation per transfer cycle
Time frame
10 weeks of gestation after recruitment3
Pregnancy loss per number of transfer cycles
Miscarriage
Time frame
less than 22 weeks of gestationSponsors and contacts
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Source ClinicalTrials.gov