Clinical trial NCT05571111: Clinical Research Study to Learn About the Effect and Safety of Different Doses of FE 999302 When Given as a Single Dose for Final Development of the Eggs After Ovarian Stimulation
Official title: A Randomised, Assessor-blind, Active-controlled, Parallel-group, Dose-finding Trial to Investigate the Efficacy and Safety of FE 999302 for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this trial is to compare three different doses of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL on oocyte maturity when administered as a single dose for final development of the oocytes in women undergoing controlled ovarian stimulation.


Eligibility criteria: Inclusion Criteria:

* Pre-menopausal women between the ages of 18 and 42 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent.
* Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
* Infertility for at least 1 year before screening for subjects \<35 years or for at least 6 months for subjects ≥35 years (not applicable in case of tubal or severe male factor infertility).
* No more than two controlled ovarian stimulation cycles initiated, regardless outcome (taking exclusion criteria 3, 4, and 5 into account).
* Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.

Exclusion Criteria:

* Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
* Considered unsuitable for controlled ovarian stimulation with a starting dose of 150 or 225 IU/day highly purified human menopausal gonadotropin (HP-hMG), as judged by the investigator.
* Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day or higher. Poor response is defined as \<4 oocytes retrieved, or cycle cancellation prior to oocyte retrieval due to inadequate follicular development.
* Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/hMG dose of ≤225 IU, defined as ≥25 oocytes retrieved or cycle cancellation prior to oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
* Severe OHSS in a previous controlled ovarian stimulation cycle.

Primary outcomes:
measure: Number of metaphase II (MII) oocytes
timeFrame: On the day of oocyte retrieval (2 days after triggering)
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: On the day of oocyte retrieval (2 days after triggering)
measure: Number of fertilised (2 pronuclei) oocytes
timeFrame: On day 1 insemination (3 days after triggering)
measure: Number and quality of embryos on day 3 after oocyte retrieval
timeFrame: Day 3 after insemination (5 days after triggering)
measure: Number and quality of blastocysts on day 5 after oocyte retrieval
timeFrame: Day 5 after insemination (7 days after triggering)
measure: Serum hormone concentrations of progesterone
timeFrame: Blood samples for analysis of circulating concentrations of progesterone will be drawn at several visits from day of triggering up to 22 days after triggering
measure: Serum hormone concentrations of 17-OH-progesterone
timeFrame: Blood samples for analysis of circulating concentrations of 17-OH-progesterone will be drawn at several visits from day of triggering up to 22 days after triggering
measure: Serum hormone concentrations of estradiol
timeFrame: Blood samples for analysis of circulating concentrations of estradiol will be drawn at several visits from day of triggering up to 22 days after triggering
measure: Serum hormone concentrations of follicle stimulating hormone (FSH)
timeFrame: Blood samples for analysis of circulating concentrations of follicle stimulating hormone (FSH) will be drawn at several visits from day of triggering up to 22 days after triggering
measure: Serum hormone concentrations of luteinising hormone (LH)
timeFrame: Blood samples for analysis of circulating concentrations of luteinising hormone (LH) will be drawn at several visits from day of triggering up to 22 days after triggering
measure: Positive βhCG (positive serum βhCG test 13-15 days after transfer)
timeFrame: 20-22 days after triggering
measure: Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer)
timeFrame: 6-7 weeks after triggering
measure: Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)
timeFrame: 6-7 weeks after triggering
measure: Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)
timeFrame: 11-12 weeks after triggering
measure: Serum hCG concentrations at end-of-stimulation, the day after triggering, at oocyte retrieval, on day 5 after oocyte retrieval (transfer), and on day 7-9 after oocyte retrieval (mid luteal phase)
timeFrame: Blood samples for analysis of circulating concentrations of hCG will be drawn at several visits from day of triggering up to 9-11 days after triggering
measure: Ovarian hyperstimulation syndrome (OHSS), overall and by timing, grade, and severity
timeFrame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS)
measure: Injection site reactions (redness, pain, itching, swelling, and bruising) assessed by the subject following administration of investigational medicinal product (IMP)
timeFrame: Immediately, 30 minutes, and 24 hours after injection
measure: Treatment-induced anti-hCG antibodies, overall as well as with neutralising capacity
timeFrame: Day of triggering up until 19-28 days after triggering
measure: Multi-fetal gestation
timeFrame: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
measure: Biochemical pregnancy
timeFrame: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
measure: Spontaneous abortion
timeFrame: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
measure: Ectopic pregnancy (with and without medical/surgical intervention)
timeFrame: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
measure: Vanishing twins
timeFrame: From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ferring Investigational Site
city: Sevilla
country: Spain
facility: Ferring Investigational Site
city: Valencia
country: Spain
facility: Ferring Investigational Site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: