Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®

Ferring

Status: Terminated

Conditions: Controlled Ovarian Stimulation

Treatments: Drug: Follitropin Delta

Study type: Observational

Funder types: Industry

Identifiers

NCT03697031

000317

Details and patient eligibility

About

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.

Enrollment: 362 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

362 participants in 1 patient group

REKOVELLE®

Description:

Follitropin Delta

Treatment:

Drug: Follitropin Delta