The Impact of Frozen - Thawed Blastocyst Morphological Development and Blastocoele Re-expansion on Clinical Pregnancy Outcome After One Controlled Ovarian Stimulation Cycle Using REKOVELLE®
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 362
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy rate
Study Overview
Brief Summary
The purpose of this observational study is to examine the development and appearance of embryos before and after freezing following a single controlled ovarian stimulation cycle using REKOVELLE® (follitropin delta) as the recombinant follicular stimulating hormone (rFSH) for controlled ovarian stimulation. The primary objective of the study is to examine how specific factors of embryo development or appearance are related to the chance of becoming pregnant.
The ovarian stimulation protocol with REKOVELLE®, a new rFSH prescribed for ovarian stimulation, is individualised with a dosing regimen that is based on two parameters: the body weight and the level of a hormone, the anti-Müllerian hormone, (AMH), a parameter used to predict how the ovaries will respond to the ovarian stimulation.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing elective single embryo transfer (e-SET) in a frozen embryo replacement (FER) treatment where the frozen blastocyst was obtained from an IVF or intracytoplasmic sperm injection (ICSI) cycle following controlled ovarian stimulation with REKOVELLE® .
- •Women are prescribed REKOVELLE® for their IVF or ICSI according to the approved label.
- •Morphological measurements and clinical outcomes are available for the fresh embryos obtained from the IVF or ICSI cycle.
- •Willing and able to understand Danish or English patient information.
- •Willingness and ability to provide written informed consent.
Exclusion Criteria
- •Patients with any contraindication for treatment with REKOVELLE® for controlled ovarian stimulation.
- •Patients with contraindication for undergoing assisted reproductive technologies (ART) such as an IVF or ICSI cycle.
- •Oocyte donors.
Arms & Interventions
REKOVELLE®
Follitropin Delta
Intervention: Follitropin Delta (Drug)
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: 7 weeks after each embryo transfer
Clinical pregnancy is defined as at least one intrauterine gestational sac with fetal heart beat at week 7, from frozen thawed blastocysts. The correlation between morphological parameters (blastocyst score, timelapse score, blastocoele re-expansion) and clinical pregnancy rate will be assessed.
Secondary Outcomes
- Use of the algorithm-based individualized dosing regimen with REKOVELLE®(At the day of the consultation visit where the daily dose of REKOVELLE® is decided)
- Day of REKOVELLE® stimulation start(At the day of the first REKOVELLE® injection during the ovarian stimulation treatment)
- Any deviation in REKOVELLE® administration(From day 1 up to day 20 of REKOVELLE® stimulation)
- Daily dose of REKOVELLE® administered(From day 1 up to day 20 of REKOVELLE® stimulation)
- Day of REKOVELLE® stimulation end(At the day of the last REKOVELLE® injection during the ovarian stimulation treatment)
- Cumulative clinical pregnancy rate(Up to 24 months)
- Positive βhCG result (blood or urinary pregnancy test)(Up to 24 months)
- Number of days of treatment with REKOVELLE®(From day 1 up to day 20 of REKOVELLE® stimulation)