Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Subfertility Drug: Dydrogesterone Drug: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 716 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Drug: Dydrogesterone
Progesterone
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.
Drug: Placebo
Placebo with appearance similar to Dydrogesterone




Primary Outcome Measures :
  1. live birth rate [ Time Frame: 10 months after recruitment ]
    the number of live birth beyond 22 weeks gestation per transfer cycle


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Pregnancy loss per number of transfer cycles [ Time Frame: less than 22 weeks of gestation ]
    Miscarriage



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of women <43 years at the time of stimulated IVF
  • Replacing early cleavage embryos or blastocysts after thawing

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859921


Contacts
Layout table for location contacts
Contact: Ernest HY Ng, MD 852-28553400 nghye@hku.hk

Locations
Layout table for location information
China, Hong Kong
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Ernest HY Ng, MD The University of Hong Kong
Layout table for additonal information
Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03859921    
Other Study ID Numbers: UW 18-594
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs