NCT03763786

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

November 26, 2018

Last Update Submit

April 23, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Live Birth Rate

    Livebirth rate per FET treatment cycle

    To treatment or pregnancy end (up to 9 months)

Secondary Outcomes (1)

  • Cancellation rate

    Through study completion (18 months)

Other Outcomes (1)

  • Clinical Pregnancy Rate

    To treatment or pregnancy end (up to 9 months)

Study Arms (2)

No GnRH antaogonist

EXPERIMENTAL

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

Drug: Cetrorelix Acetate

Standard GnRH antoagonist

ACTIVE COMPARATOR

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

Drug: Cetrorelix Acetate

Interventions

Cetrorelix AcetateDRUG

Used a standard

Also known as: Cetrotide
No GnRH antaogonistStandard GnRH antoagonist

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Willing and able to give informed consent for participation in the study.
  • Planning to undergo medicated FET
  • Blastocyst embryo in storage available for transfer

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Fertility

Oxford, OX4 2HW, United Kingdom

Location

MeSH Terms

Conditions

Infertility

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

December 4, 2018

Study Start

December 13, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 25, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)