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A Study of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen Embryo Transfer

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ClinicalTrials.gov Identifier: NCT01931384
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief 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.


Condition or disease Intervention/treatment Phase
Subfertility Drug: Human chorionic gonadotrophin Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Comparison of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles
Study Start Date : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
luteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later.
Drug: Human chorionic gonadotrophin
luteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later.

Placebo Comparator: control group
normal saline (placebo) intramuscular injection will be given on the day of FET and 6 days later
Drug: Placebo
Normal saline intramuscularly on the day of embryo transfer and 5 days after embryo transfer.
Other Name: Normal saline




Primary Outcome Measures :
  1. ongoing pregnancy rate [ Time Frame: 4 months ]
    ongoing pregnancy rate which is defined as the number of on-going pregnancies beyond 10-12 weeks gestation per transfer cycle


Secondary Outcome Measures :
  1. Rate of pregnancy loss per number of transfer cycles [ Time Frame: 4 months ]
    The pregnancy loss after embryo transfer counted


Other Outcome Measures:
  1. Implantation rate [ Time Frame: 4 months ]
    number of gestational sacs per number of embryos transferred

  2. Hormonal profile [ Time Frame: 2 weeks ]
    Hormonal profile including the serum oestradiol, progesterone and hCG concentrations at the mid-luteal phase (day 6 after FET)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT01931384


Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Vivian Chi Yan Lee, MBBS HKU / QMH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01931384     History of Changes
Other Study ID Numbers: HKU-VL-LPSRCT
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by The University of Hong Kong:
Luteal phase support
Human chorionic gonadotrophin
frozen-thawed embryo transfer cycle
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs