Frozen Embryo Transfer With GnRH-antagonist Trial

NCT ID: NCT03763786

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-13
• Study Completion Date: 2021-01-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No GnRH antaogonist

Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days

Group Type: EXPERIMENTAL

Cetrorelix Acetate

Intervention Type: DRUG

Used a standard

Standard GnRH antoagonist

Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days

Group Type: ACTIVE_COMPARATOR

Cetrorelix Acetate

Intervention Type: DRUG

Used a standard

Interventions

Cetrorelix Acetate

Used a standard

Intervention Type: DRUG

Other Intervention Names

Cetrotide

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oxford Fertility Limited, United Kingdom

UNKNOWN

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oxford Fertility

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

2018-001915-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IRAS 243105

Identifier Type: -

Identifier Source: org_study_id