Frozen Embryo Transfer With GnRH-antagonist Trial

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Controlled Pilot Trial of the Use of GnRH-antagonist Pituitary Suppression During Medicated Frozen-thawed Embryo Transfer (FET) Cycles

Conditions
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Infertility

Intervention / Treatment
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* Drug: Cetrorelix Acetate


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No GnRH antaogonist<br>Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days | Drug: Cetrorelix Acetate<br>* Used a standard<br>* Other names: Cetrotide;|
| Active Comparator: Standard GnRH antoagonist<br>Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days | Drug: Cetrorelix Acetate<br>* Used a standard<br>* Other names: Cetrotide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth Rate | Livebirth rate per FET treatment cycle | To treatment or pregnancy end (up to 9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancellation rate | Number of cycles cancelled over number of treatment cycles started | Through study completion (18 months) |