Frozen Embryo Transfer With GnRH-antagonist Trial

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03763786
• Other study ID #: IRAS 243105
• Secondary ID: 2018-001915-63
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: December 13, 2018
• Est. completion date: January 2021

Study information

• Verified date: April 2019
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Cetrorelix Acetate
Used a standard

Locations

Country	Name	City	State
United Kingdom	Oxford Fertility	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford Fertility Limited, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	Live Birth Rate	Livebirth rate per FET treatment cycle	To treatment or pregnancy end (up to 9 months)
Secondary	Cancellation rate	Number of cycles cancelled over number of treatment cycles started	Through study completion (18 months)