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

Infertility Clinical Trial

— TIFFANY  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05571111
• Other study ID #: 000298
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 4, 2022
• Est. completion date: June 25, 2024

Study information

• Verified date: July 2022
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• FE 999302
Subcutaneous injection as a single dose. 3 different doses
• Ovitrelle
Subcutaneous injection as a single dose. 250 µg (0.5 mL)
• Novarel
Subcutaneous injection as a single dose. 10,000 IU (1 mL)

Locations

Country	Name	City	State
Spain	Ferring Investigational Site	Madrid
Spain	Ferring Investigational Site	Sevilla
Spain	Ferring Investigational Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of metaphase II (MII) oocytes		On the day of oocyte retrieval (2 days after triggering)
Secondary	Number of oocytes retrieved		On the day of oocyte retrieval (2 days after triggering)
Secondary	Number of fertilised (2 pronuclei) oocytes		On day 1 insemination (3 days after triggering)
Secondary	Number and quality of embryos on day 3 after oocyte retrieval		Day 3 after insemination (5 days after triggering)
Secondary	Number and quality of blastocysts on day 5 after oocyte retrieval		Day 5 after insemination (7 days after triggering)
Secondary	Serum hormone concentrations of progesterone		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
Secondary	Serum hormone concentrations of 17-OH-progesterone		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
Secondary	Serum hormone concentrations of estradiol		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
Secondary	Serum hormone concentrations of follicle stimulating hormone (FSH)		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
Secondary	Serum hormone concentrations of luteinising hormone (LH)		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
Secondary	Positive ßhCG (positive serum ßhCG test 13-15 days after transfer)		20-22 days after triggering
Secondary	Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer)		6-7 weeks after triggering
Secondary	Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)		6-7 weeks after triggering
Secondary	Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)		11-12 weeks after triggering
Secondary	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)		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
Secondary	Ovarian hyperstimulation syndrome (OHSS), overall and by timing, grade, and severity	Early OHSS is defined as OHSS with onset =9 days after triggering of final follicular maturation. Late OHSS is defined as OHSS with onset >9 days after triggering of final follicular maturation.	=9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS)
Secondary	Injection site reactions (redness, pain, itching, swelling, and bruising) assessed by the subject following administration of investigational medicinal product (IMP)		Immediately, 30 minutes, and 24 hours after injection
Secondary	Treatment-induced anti-hCG antibodies, overall as well as with neutralising capacity		Day of triggering up until 19-28 days after triggering
Secondary	Multi-fetal gestation		From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
Secondary	Biochemical pregnancy		From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
Secondary	Spontaneous abortion		From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
Secondary	Ectopic pregnancy (with and without medical/surgical intervention)		From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
Secondary	Vanishing twins		From day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)