Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice

NCT04503707 | Completed

• 1 other identifier: 000370
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 14

Brief Summary

The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.

Conditions

Controlled Ovarian Stimulation

Keywords

Follicle Stimulating Hormone (FSH); Assisted Reproductive Technologies (ART); Follitropin Delta; REKOVELLE

Outcome Measures

Primary Outcomes (7)

• Daily dose of REKOVELLE administered (for naïve and non-naïve subjects)

  At the end of the stimulation protocol (up to 30 days)

• Duration of treatment with REKOVELLE (for naïve and non-naïve subjects)

  From first until last day of REKOVELLE treatment (up to 30 days)

• Use of the dosing App (for naïve and non-naïve subjects)

  At visit when the daily dose of REKOVELLE is decided (up to 2 hours)

• Type of Gonadotropin-Releasing Hormone (GnRH) used (for naïve and non-naïve subjects)

  At visit (up to 2 hours) during the REKOVELLE treatment period

• Duration of treatment with GnRH (for naïve and non-naïve subjects)

  At the end of the ovarian controlled stimulation (up to 2 weeks)

• Treatment used for the triggering of follicle maturation (for naïve and non-naïve subjects)

  At the last visit during the REKOVELLE treatment period (from 5 to 30 days)

• Treatment used for Luteal phase support (for naïve and non-naïve subjects)

  Decided as a choice between Progesterone, Oestrogen and hCG

  From start of REKOVELLE treatment until 10-11 weeks after embryo transfer

Secondary Outcomes (28)

• Rate of Ongoing Pregnancy (for naïve and non-naïve subjects)

  Up to 10-11 weeks after transfer

• Number of oocytes retrieved (for naïve and non-naïve subjects)

  At visit (up to 2 hours) at 36 hours after completed REKOVELLE treatment

• Number of oocytes/embryos/blastocysts frozen (for naïve and non-naïve subjects)

  At Day 3 after oocyte retrieval

• Quality of fresh or frozen embryos or blastocysts transferred (excellent, good, fair, other) (for naïve and non-naïve subjects)

  At Day 3, 5 or 6 after oocyte retrieval

• Implantation rate (for naïve and non-naïve subjects)

  Up to 10-11 weeks after transfer

Study Arms (1)

Follitropin Delta

Treatment according to routine clinical practice.

Drug: Follitropin Delta

Interventions

Follitropin Delta DRUG

The Intervention (solution for injection) is delivered with a pre-filled injection pen. The REKOVELLE dose will be based on a recent determination (within the last 12 months) of AMH (anti- müllerian hormone) measured by the ELECSYS AMH Plus Immunoassay.

Also known as: REKOVELLE

Follitropin Delta

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women who are prescribed REKOVELLE within the approved indication for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment will be invited to participate in the study. Subjects will be enrolled only after the treatment decision has been made and no aspect of this study will interfere with or influence the routine medical procedures and/or medications received.

You may qualify if:

• Females aged 18 years or older at enrolment
• Who are treated for IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor
• Who are prescribed REKOVELLE for the first time and using the dosing algorithm to define the dose regimen: a previous cycle with REKOVELLE should not be allowed
• Who have been informed verbally and in writing about this study content and who do not object to their data being electronically processed.

You may not qualify if:

• Participating in an interventional clinical trial in which any treatment or follow-up is mandated
• Women with a contraindication for prescription of REKOVELLE treatment
• Oocyte donors
• Women undergoing ovarian stimulation for fertility preservation
• Women undergoing their third or fourth attempt of IVF or ICSI for the current parental project.
• Subject non-affiliated to French Social Security
• Women placed under judicial protection, guardianship, or supervision

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (14)

Hôpital Pellegrin

Bordeaux, France

Location

Hôpital Femme Mère Enfant

Bron, France

Location

Hopital Antoine Béclère

Clamart, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Location

Centre hospitalier de Lille-Hopital de Flandre

Lille, France

Location

Institut de Médecine de la Reproduction (there may be other sites in this country)

Marseille, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nantes Hôpital Hôtel Dieu

Nantes, France

Location

Maternité Port Royal

Paris, France

Location

Centre Hospitalier Intercommunal de Poissy

Poissy, France

Location

Clinique Mutualiste La Sagesse

Rennes, France

Location

Pierre OGER

Rueil-Malmaison, France

Location

CMCO

Strasbourg, France

Location

CHU Toulouse - Hôpital Paule de Viguier

Toulouse, France

Location

MeSH Terms

Interventions

follitropin delta

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: August 7, 2020
• Study Start: June 17, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-11

Locations

FR (14)