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Frozen Embryo Transfer With GnRH-antagonist Trial

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Cetrorelix Acetate
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Oxford Fertility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No GnRH antaogonist

Standard GnRH antoagonist

Arm Description

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

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

Outcomes

Primary Outcome Measures

Live Birth Rate
Livebirth rate per FET treatment cycle

Secondary Outcome Measures

Cancellation rate
Number of cycles cancelled over number of treatment cycles started

Full Information

First Posted
November 26, 2018
Last Updated
April 23, 2019
Sponsor
University of Oxford
Collaborators
Oxford Fertility Limited, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03763786
Brief Title
Frozen Embryo Transfer With GnRH-antagonist Trial
Official Title
A Randomised Controlled Pilot Trial of the Use of GnRH-antagonist Pituitary Suppression During Medicated Frozen-thawed Embryo Transfer (FET) Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford Fertility Limited, United Kingdom

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No GnRH antaogonist
Arm Type
Experimental
Arm Description
Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days
Arm Title
Standard GnRH antoagonist
Arm Type
Active Comparator
Arm Description
Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days
Intervention Type
Drug
Intervention Name(s)
Cetrorelix Acetate
Other Intervention Name(s)
Cetrotide
Intervention Description
Used a standard
Primary Outcome Measure Information:
Title
Live Birth Rate
Description
Livebirth rate per FET treatment cycle
Time Frame
To treatment or pregnancy end (up to 9 months)
Secondary Outcome Measure Information:
Title
Cancellation rate
Description
Number of cycles cancelled over number of treatment cycles started
Time Frame
Through study completion (18 months)
Other Pre-specified Outcome Measures:
Title
Clinical Pregnancy Rate
Description
Defined as number of intrauterine pregnancies with at least one fetal heart visible on an early pregnancy ultrasound scan per treatment cycle.
Time Frame
To treatment or pregnancy end (up to 9 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Oxford Fertility
City
Oxford
ZIP/Postal Code
OX4 2HW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Frozen Embryo Transfer With GnRH-antagonist Trial

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