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

Ferring Pharmaceuticals250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Controlled Ovarian Stimulation

Interventions

Follitropin DeltaDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (14)

Hôpital Pellegrin

Bordeaux, France

Hôpital Femme Mère Enfant

Bron, France

Hopital Antoine Béclère

Clamart, France

Outcomes

Primary Outcomes

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

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

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

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

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

Time frame: 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)

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

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

Time frame: 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)

Time frame: 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

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

Secondary Outcomes

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

Ongoing pregnancy is defined as at least one intrauterine viable fetus, 10-11 weeks after first fresh or frozen embryo/blastocyst transfer.

Time frame: Up to 10-11 weeks after transfer

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Centre hospitalier de Lille-Hopital de Flandre

Lille, France

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

Marseille, France

CHU Montpellier

Montpellier, France

CHU Nantes Hôpital Hôtel Dieu

Nantes, France

Maternité Port Royal

Paris, France

Centre Hospitalier Intercommunal de Poissy

Poissy, France

...and 4 more locations

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

Time frame: 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)

Time frame: 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)

Time frame: At Day 3, 5 or 6 after oocyte retrieval

Implantation rate (for naïve and non-naïve subjects)

Implantation rate is defined as number of intrauterine viable fetus after transfer divided by the number of embryos/blastocysts transferred.

Time frame: Up to 10-11 weeks after transfer

Positive human chorionic gonadotropin (hCG) test (for naïve and non-naïve subjects)

Proportion of subjects with positive hCG test.

Time frame: Up to 10-11 weeks after transfer

Clinical pregnancy rate (for naïve and non-naïve subjects)

Clinical pregnancy is defined as least one gestational sac.

Time frame: Up to 5-6 weeks after transfer

Incidence of biochemical pregnancy (for naïve and non-naïve subjects)

Biochemical pregnancy is defined as positive beta hCG (βhCG) test but no gestational sac is observed on later transvaginal ultrasound, or menstruation is reported.

Time frame: Up to 10-11 weeks after transfer

Incidence of spontaneous abortion (for naïve and non-naïve subjects)

Spontaneous abortion is defined as positive βhCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there are no viable fetuses observed by ultrasound.

Time frame: Up to 10-11 weeks after transfer

Incidence of elective abortion (for naïve and non-naïve subjects)

Elective abortion is defined as induced abortion done at the request of the woman for other than therapeutic reasons.

Time frame: Up to 10-11 weeks after transfer

Incidence of vanishing twins (for naïve and non-naïve subjects)

Vanishing twin is defined as spontaneous disappearance of an intrauterine gestational sac with or without heart beat in a pregnancy where one viable fetus remains as documented by ultrasound.

Time frame: Up to 10-11 weeks after transfer

Incidence of ectopic pregnancy (for naïve and non-naïve subjects)

Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.

Time frame: Up to 10-11 weeks after transfer

Proportion of subjects with cycle cancellation (for naïve and non-naïve subjects)

Cancellation could be done before oocyte pick up (due to poor ovarian response, excessive ovarian response, any illness which prevents oocyte collection procedure, subject not taking hCG injection at the correct time, subject choice, other) or after oocyte pick up (due to no oocytes collected, no oocytes fertilized, abnormal fertilization, abnormal embryo development, no embryo development, ovarian hyperstimulation syndrome (OHSS), subject choice, other)

Time frame: Up to 10-11 weeks after transfer

Type of gonadotropin used (previous cycle information for non-naïve subjects)

Time frame: At baseline

Dose of gonadotropin used (previous cycle information for non-naïve subjects)

Time frame: At baseline

Duration of treatment with gonadotropin (previous cycle information for non-naïve subjects)

Time frame: At baseline

Type of GnRH used (previous cycle information for non-naïve subjects)

Defined as a choice between GnRH agonist and GnRH antagonist

Time frame: At baseline

Duration of treatment with GnRH (previous cycle information for non-naïve subjects)

Time frame: At baseline

Treatment used for the triggering of follicle maturation (previous cycle information for non-naïve subjects)

Time frame: At baseline

Treatment used for Luteal phase support (previous cycle information for non-naïve subjects)

Decided as a choice between Progesterone, Oestrogen and hCG

Time frame: At baseline

Number of oocytes retrieved (previous cycle information for non-naïve subjects)

Time frame: At baseline

Number of embryos/blastocysts transferred (previous cycle information for non-naïve subjects)

Time frame: At baseline

Incidence of pregnancy loss in women with embryo/blastocyst transfer (previous cycle information for non-naïve subjects)

Pregnancy loss included biochemical pregnancy, spontaneous / elective abortion, ectopic pregnancy.

Time frame: At baseline

Proportion of subjects with OHSS including moderate/severe grade (previous cycle information for non-naïve subjects)

Each OHSS case will be classified as moderate or severe.

Time frame: At baseline

Proportion of subjects with preventive interventions for early OHSS (previous cycle information for non-naïve subjects)

Preventive interventions cover triggering of final follicular maturation with GnRH agonist and fresh embryo/blastocyst transfer or cryopreservation of oocytes/embryos/blastocysts, cycle cancellation, coasting.

Time frame: At baseline

Proportion of subjects with preventive interventions for early OHSS (for naïve and non-naïve subjects)

Time frame: Up to 10-11 weeks after transfer

Frequency of adverse drug reactions (ADR) (for naïve and non-naïve subjects)

An ADR is characterized by the causal relationship between REKOVELLE and the adverse event is at least a reasonable possibility.

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

Monitoring of the REKOVELLE treatment (number and intents of each visit) (for naïve and non-naïve subjects)

Time frame: From Day 1 up to the last day of REKOVELLE stimulation