Frozen Embryo Transfer With GnRH-antagonist Trial

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

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.

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Drug: Cetrorelix Acetate

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX4 2HW
    • Oxford Fertility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: No GnRH antaogonist; Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days	Drug: Cetrorelix Acetate; Used a standard; Other Names: Cetrotide
ACTIVE_COMPARATOR: Standard GnRH antoagonist; Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days	Drug: Cetrorelix Acetate; Used a standard; Other Names: Cetrotide

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate	Defined as number of intrauterine pregnancies with at least one fetal heart visible on an early pregnancy ultrasound scan per treatment cycle.	To treatment or pregnancy end (up to 9 months)

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Oxford Fertility Limited, United Kingdom

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2018
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (ACTUAL): December 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Cetrorelix
• Other Study ID Numbers: IRAS 243105; 2018-001915-63 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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