Frozen Embryo Transfer With GnRH-antagonist Trial
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Cetrorelix Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Willing and able to give informed consent for participation in the study.
- Planning to undergo medicated FET
- Blastocyst embryo in storage available for transfer
Exclusion Criteria:
- Previously randomised into the trial.
- A history of 3 or more consecutive implantation failures (after fresh or frozen embryo transfer).
- A history of recurrent miscarriage (3 or more consecutive miscarriages).
- Contraindication to the use of medications for FET cycle.
- Biopsied embryos.
- Donor embryos or eggs (use of donor sperm is not excluded).
Sites / Locations
- Oxford Fertility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No GnRH antaogonist
Standard GnRH antoagonist
Arm Description
Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days
Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days
Outcomes
Primary Outcome Measures
Live Birth Rate
Livebirth rate per FET treatment cycle
Secondary Outcome Measures
Cancellation rate
Number of cycles cancelled over number of treatment cycles started
Full Information
NCT ID
NCT03763786
First Posted
November 26, 2018
Last Updated
April 23, 2019
Sponsor
University of Oxford
Collaborators
Oxford Fertility Limited, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT03763786
Brief Title
Frozen Embryo Transfer With GnRH-antagonist Trial
Official Title
A Randomised Controlled Pilot Trial of the Use of GnRH-antagonist Pituitary Suppression During Medicated Frozen-thawed Embryo Transfer (FET) Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford Fertility Limited, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The fertility treatment in vitro fertilisation (IVF), sometimes including intra-cytoplasmic sperm injection (ICSI), involves the creation of embryos in a laboratory. These embryos are then transferred into the womb of the patient with the hope of a resulting pregnancy and live birth. Embryos can also be cryopreserved (frozen) and stored, and then later replaced in a cycle called frozen embryo transfer (FET). There are several methods of preparing the patient's womb to receive the frozen-thawed embryo(s) but commonly embryos are replaced during a medicated cycle. Usually oestrogen and progesterone are administered to prepare the womb lining for embryo transfer at the appropriate time, and in addition a drug called a GnRH antagonist is administered to prevent a women's own hormones from interfering with this process as it is thought this might lead to higher numbers of cycles being cancelled. However, there is some suspicion that this drug (GnRH antagonist) may not be required and that women are using this drug unnecessarily.
Some clinics do not use GnRH antagonists in FET cycles, but the investigators do not know if they have higher rates of cancelled cycles as a result.
This pilot study aims to compare cycles of medicated FET using oestrogen and progesterone, either with or without pituitary suppression in the form of GnRH antagonist (Cetrotide), in patients over the next 18 months who are planning FET cycles at Oxford Fertility, UK to find out if both give the same chance of having a baby, which treatment is better for patients and to assess the feasibility of undertaking a future larger study. Cetrotide is a marketed and well-known medication and any risk or serious adverse effects are unlikely. The study is an open label prospective randomised controlled trial. Funding for the medication (Cetrotide) is provided by Oxford Fertility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No GnRH antaogonist
Arm Type
Experimental
Arm Description
Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days
Arm Title
Standard GnRH antoagonist
Arm Type
Active Comparator
Arm Description
Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days
Intervention Type
Drug
Intervention Name(s)
Cetrorelix Acetate
Other Intervention Name(s)
Cetrotide
Intervention Description
Used a standard
Primary Outcome Measure Information:
Title
Live Birth Rate
Description
Livebirth rate per FET treatment cycle
Time Frame
To treatment or pregnancy end (up to 9 months)
Secondary Outcome Measure Information:
Title
Cancellation rate
Description
Number of cycles cancelled over number of treatment cycles started
Time Frame
Through study completion (18 months)
Other Pre-specified Outcome Measures:
Title
Clinical Pregnancy Rate
Description
Defined as number of intrauterine pregnancies with at least one fetal heart visible on an early pregnancy ultrasound scan per treatment cycle.
Time Frame
To treatment or pregnancy end (up to 9 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to give informed consent for participation in the study.
Planning to undergo medicated FET
Blastocyst embryo in storage available for transfer
Exclusion Criteria:
Previously randomised into the trial.
A history of 3 or more consecutive implantation failures (after fresh or frozen embryo transfer).
A history of recurrent miscarriage (3 or more consecutive miscarriages).
Contraindication to the use of medications for FET cycle.
Biopsied embryos.
Donor embryos or eggs (use of donor sperm is not excluded).
Facility Information:
Facility Name
Oxford Fertility
City
Oxford
ZIP/Postal Code
OX4 2HW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Frozen Embryo Transfer With GnRH-antagonist Trial
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