A Study of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen Embryo Transfer
Information source: The University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subfertility
Intervention: Human chorionic gonadotrophin (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: The University of Hong Kong Official(s) and/or principal investigator(s): Vivian Chi Yan Lee, MBBS, Principal Investigator, Affiliation: HKU / QMH
Overall contact: Vivian Chi Yan Lee, MBBS, Phone: 852-22553400
Summary
A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer
cycles.
The hypothesis of the study is that the use of luteal phase support with human chorionic
gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.
Clinical Details
Official title: A Randomized Controlled Comparison of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: ongoing pregnancy rate
Secondary outcome: Rate of pregnancy loss per number of transfer cycles
Detailed description:
Trial design:
- A total of 450 women undergoing FET in the Centre of Assisted Reproduction and Embryology,
The University of Hong Kong-Queen Mary Hospital, will be recruited. They will be randomized
into one of the following two groups by computer-generated random numbers:
Group I: luteal phase support using HCG 1500 IU intramuscular injection will be given on the
day of FET and 6 days later.
Group II: normal saline (placebo) intramuscular injection will be given on the day of FET
and 6 days later.
Treatment:
Ovarian stimulation protocol:
All women received ovarian stimulation according to the standard protocol of the Centre. HCG
is given intramuscularly when the leading follicle reaches 18 mm in mean diameter. Oocyte
retrieval is carried out 36 hours after the HCG trigger. A maximum of two embryos will
transferred and any excess good quality embryos will be frozen two days after the retrieval.
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 and there is at least one frozen embryo. Frozen
embryos after thawing are transferred in natural cycles for those women having regular
ovulatory cycles, during which the patient is monitored daily for serum estradiol ad
luteinising hormone levels from 18 days before the expected date of the next period.
The transfer is performed by the team clinician on the third day after the luteinising
hormone surge and a maximum of two normally cleaving embryos are replaced according to our
standard protocol. The luteal phase is supported as per randomization arm. Before the
embryo transfer, the patient is interviewed by a designated research nurse who will explain
the purpose of this study. Patients consenting to take part in the study will be assigned
into one of the two study arms specified in an opaque envelope according to a
computer-generated randomization list. The envelope will be read and injection (HCG or
placebo as normal saline) given by a service nurse not involved in the study. Blood will be
taken on day 6 after FET before the patient receives the second dose of HCG or placebo. 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 continued in those who get pregnant.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Normal uterine cavity shown on pelvic scanning during the stimulated IVF cycle
- Endometrial thickness >=8mm in FET cycles
Exclusion Criteria:
- Subjects requiring clomid-induced cycles and hormonal replacement (HRT) cycles
- History of previous FET cycles within the study period
- Blastocyst transfer
- Use of donor oocytes
- Presence of hydrosalpinx not corrected surgically prior to FET
- Refusal to join the study
Locations and Contacts
Vivian Chi Yan Lee, MBBS, Phone: 852-22553400
The University of Hong Kong, Hong Kong, Hong Kong; Recruiting Vivian Chi Yan Lee, MBBS, Phone: 852-22553400 Vivian Chi Yan Lee, MBBS, Principal Investigator
Additional Information
Starting date: July 2012
Last updated: May 27, 2015
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