Trial · Interventional
Status unknownPhase 4Registry dataFrozen Embryo Transfer With GnRH-antagonist Trial
Overview
- Status
- Status unknown
- Phase
- Phase 4
- Enrollment
- 300 participants (estimated)
- Sponsor
- University of Oxford · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United Kingdom
- Start
- 13 Dec 2018
- Primary completion
- Jan 2021 (estimated)
- Completion
- Jan 2021 (estimated)
- First posted
- 4 Dec 2018
- Last update posted
- 25 Apr 2019
- Conditions
- Infertility
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Cetrorelix AcetateDrug
Arms2
Experimental
No GnRH antaogonist
Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days
Active comparator
Standard GnRH antoagonist
Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days
Primary outcomes1
Outcomes the sponsor listed as primary.
Live Birth Rate
Time frame · To treatment or pregnancy end (up to 9 months)
Registry description
Livebirth rate per FET treatment cycle
Secondary outcomes(1)
Cancellation rate
Time frame · Through study completion (18 months)
Registry description
Number of cycles cancelled over number of treatment cycles started
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 42 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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