SubfertilityPhase 3NCT03859921
Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET
A Phase 3 study testing Dydrogesterone in people with Subfertility, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Dydrogesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 716 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age of women <43 years at the time of stimulated IVF
- Replacing early cleavage embryos or blastocysts after thawing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong
Ernest HY NG, MD, 852-22553400, nghye@hku.hk
Ernest HY NG, MD
About this study
Official title: A Randomized Double Blind Controlled Comparison of Oral Dydrogesterone as Luteal Phase Support in Natural Cycle Frozen-thawed Embryo Transfer
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.
Read the detailed description
Trial design:
Women undergoing FET in the Centre of Assisted Reproduction and Embryology, The University of Hong Kong-Queen Mary Hospital, will be recruited and will be randomized into one of the following two study groups:
Treatment group: Oral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation.
Control group: Placebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation.
Treatment of subjects
Ovarian stimulation protocol:
All women received ovarian stimulation according to the standard protocol of the Centre. Egg collection is carried out 36 hours after the HCG trigger. One to two early cleaving embryos or blastocysts will be transferred and any excess good quality cleaving embryos or blastocyst will be frozen two to six days after egg collection.
FET cycle:
FET is carried out at least 2 month after the stimulated cycle if the patient fails to get pregnant in the stimulated IVF cycle. Frozen cleaving embryos or blastocysts after thawing are transferred in natural cycles for those women having regular ovulatory cycles. Women are monitored daily from 18 days before the expected date of he next period for pelvic ultrasound assessment of the size of the leading follicle and determination of serum oestradiol (E2) and LH concentrations until the LH surge, which is defined by the LH level being above 20 IU/L and more than double of the average of the LH levels over the past three days. HCG can also be given when the leading follicle reaches 17mm in diameter.
Women will be counseled by a designated research nurse who will explain the purpose of this study when they first attend the clinic for FET. On the day of the hCG trigger or one day after the LH surge, those who consent to join the study will be randomized into one of the two study arms specified in an opaque envelope according to a computer-generated randomization list prepared by a research nurse who is not involved in the present study. Oral dydrogesterone and placebo tablets have the same appearance and will be started one day after the hCG trigger or the LH surge for two weeks.
The transfer is performed on the third day after the LH surge or the fourth day after the hCG trigger for frozen cleaving embryos (on the sixth day after the LH surge or the seventh day after hCG trigger for frozen blastocysts). Again 1-2 cleaving embryos are replaced according to our standard protocol. A urine pregnancy test will be performed 16 days after the FET. In case of pregnancy, the outcome of pregnancy will be traced afterwards and used for analysis. Luteal phase support is not required in those who get pregnant.
- Conditions
- Subfertility
- Being tested
- Dydrogesterone, Placebo
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DydrogesteroneDrug
Also called Duphaston
Progesterone
PlaceboDrug
Placebo with appearance similar to Dydrogesterone
| Study group | Role | What they receive |
|---|---|---|
| Dydrogesterone group | Experimental | Oral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation. Receives: Drug: Dydrogesterone |
| Placebo group | Placebo comparator | Placebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
the number of live birth beyond 22 weeks gestation per transfer cycle
Measured: 10 months after recruitment
Secondary outcomes (3)
Clinical pregnancy rate
the number of women with an intrauterine gestational sac at 5-6 weeks of gestation
Measured: 6 weeks of gestation after recruitment
Ongoing pregnancy rate
the number of intrauterine pregnancies with fetal pulsation beyond 10 gestation per transfer cycle
Measured: 10 weeks of gestation after recruitment
Pregnancy loss per number of transfer cycles
Miscarriage
Measured: less than 22 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Jul 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernest HY Ng, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859921
- Sponsor's protocol ID
- UW 18-594
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2019
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Controlled Comparison of Oral Dydrogesterone as Luteal Phase Support in Natural Cycle Frozen-thawed Embryo Transfer
- ClinicalTrials.gov ID
- NCT03859921
- Acronym / sponsor ID
- UW 18-594
- Conditions
- Subfertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 716 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trial design:
Women undergoing FET in the Centre of Assisted Reproduction and Embryology, The University of Hong Kong-Queen Mary Hospital, will be recruited and will be randomized into one of the following two study groups:
Treatment group: Oral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation.
Control group: Placebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation.
Treatment of subjects
Ovarian stimulation protocol:
All women received ovarian stimulation according to the standard protocol of the Centre. Egg collection is carried out 36 hours after the HCG trigger. One to two early cleaving embryos or blastocysts will be transferred and any excess good quality cleaving embryos or blastocyst will be frozen two to six days after egg collection.
FET cycle:
FET is carried out at least 2 month after the stimulated cycle if the patient fails to get pregnant in the stimulated IVF cycle. Frozen cleaving embryos or blastocysts after thawing are transferred in natural cycles for those women having regular ovulatory cycles. Women are monitored daily from 18 days before the expected date of he next period for pelvic ultrasound assessment of the size of the leading follicle and determination of serum oestradiol (E2) and LH concentrations until the LH surge, which is defined by the LH level being above 20 IU/L and more than double of the average of the LH levels over the past three days. HCG can also be given when the leading follicle reaches 17mm in diameter.
Women will be counseled by a designated research nurse who will explain the purpose of this study when they first attend the clinic for FET. On the day of the hCG trigger or one day after the LH surge, those who consent to join the study will be randomized into one of the two study arms specified in an opaque envelope according to a computer-generated randomization list prepared by a research nurse who is not involved in the present study. Oral dydrogesterone and placebo tablets have the same appearance and will be started one day after the hCG trigger or the LH surge for two weeks.
The transfer is performed on the third day after the LH surge or the fourth day after the hCG trigger for frozen cleaving embryos (on the sixth day after the LH surge or the seventh day after hCG trigger for frozen blastocysts). Again 1-2 cleaving embryos are replaced according to our standard protocol. A urine pregnancy test will be performed 16 days after the FET. In case of pregnancy, the outcome of pregnancy will be traced afterwards and used for analysis. Luteal phase support is not required in those who get pregnant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dydrogesterone group | Experimental | Drug: DydrogesteroneOral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age of women <43 years at the time of stimulated IVF
- Replacing early cleavage embryos or blastocysts after thawing
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DydrogesteroneAlso: DuphastonProgesterone | Drug | Dydrogesterone group |
| PlaceboPlacebo with appearance similar to Dydrogesterone | Drug | Placebo group |
Primary outcome
live birth rate
Time frame: 10 months after recruitment
the number of live birth beyond 22 weeks gestation per transfer cycle
3 secondary outcomes
Clinical pregnancy rate
Time frame: 6 weeks of gestation after recruitment
Ongoing pregnancy rate
Time frame: 10 weeks of gestation after recruitment
Pregnancy loss per number of transfer cycles
Time frame: less than 22 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ernest HY Ng, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dydrogesterone in people with Subfertility, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ernest HY Ng, MD (852-28553400, nghye@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: 10 months after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.