Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03859921|
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Subfertility||Drug: Dydrogesterone Drug: Placebo||Phase 3|
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 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||716 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Double Blind Controlled Comparison of Oral Dydrogesterone as Luteal Phase Support in Natural Cycle Frozen-thawed Embryo Transfer|
|Estimated Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 30, 2023|
Experimental: Dydrogesterone group
Oral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation.
Other Name: Duphaston
Placebo Comparator: Placebo group
Placebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation.
Placebo with appearance similar to Dydrogesterone
- live birth rate [ Time Frame: 10 months after recruitment ]the number of live birth beyond 22 weeks gestation per transfer cycle
- Clinical pregnancy rate [ Time Frame: 6 weeks of gestation after recruitment ]the number of women with an intrauterine gestational sac at 5-6 weeks of gestation
- Ongoing pregnancy rate [ Time Frame: 10 weeks of gestation after recruitment ]the number of intrauterine pregnancies with fetal pulsation beyond 10 gestation per transfer cycle
- Pregnancy loss per number of transfer cycles [ Time Frame: less than 22 weeks of gestation ]Miscarriage
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859921
|Contact: Ernest HY Ng, MDemail@example.com|
|China, Hong Kong|
|Department of Obstetrics and Gynaecology|
|Hong Kong, Hong Kong, China|
|Principal Investigator:||Ernest HY Ng, MD||The University of Hong Kong|