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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 (TIFFANY)

Primary Purpose

Infertility

Status

Withdrawn

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

FE 999302

Ovitrelle

Novarel

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Ferring Investigational Site
Ferring Investigational Site
Ferring Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Dose 1 of FE 999302

Dose 2 of FE 999302

Dose 3 of FE 999302

250 μg OVITRELLE

10,000 IU NOVAREL

Arm Description

Subcutaneous injection of Dose 1 of FE 999302 as a single dose.

Subcutaneous injection of Dose 2 of FE 999302 as a single dose.

Subcutaneous injection of Dose 3 of FE 999302 as a single dose.

Subcutaneous injection of 250 μg of OVITRELLE. 0.5 mL as a single dose.

Subcutaneous injection of 10,000 IU NOVAREL. 1 mL as a single dose.

Outcomes

Primary Outcome Measures

Number of metaphase II (MII) oocytes

Secondary Outcome Measures

Number of oocytes retrieved

Number of fertilised (2 pronuclei) oocytes

Number and quality of embryos on day 3 after oocyte retrieval

Number and quality of blastocysts on day 5 after oocyte retrieval

Serum hormone concentrations of progesterone

Serum hormone concentrations of 17-OH-progesterone

Serum hormone concentrations of estradiol

Serum hormone concentrations of follicle stimulating hormone (FSH)

Serum hormone concentrations of luteinising hormone (LH)

Positive βhCG (positive serum βhCG test 13-15 days after transfer)

Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer)

Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)

Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)

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)

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.

Injection site reactions (redness, pain, itching, swelling, and bruising) assessed by the subject following administration of investigational medicinal product (IMP)

Treatment-induced anti-hCG antibodies, overall as well as with neutralising capacity

Multi-fetal gestation

Biochemical pregnancy

Spontaneous abortion

Ectopic pregnancy (with and without medical/surgical intervention)

Vanishing twins

Full Information

NCT ID

NCT05571111

First Posted

September 28, 2022

Last Updated

January 5, 2023

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05571111

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Based on company decision to close the project. No trial participants received any study drug.

Study Start Date

October 4, 2022 (Actual)

Primary Completion Date

March 25, 2024 (Anticipated)

Study Completion Date

June 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose 1 of FE 999302

Arm Type

Experimental

Arm Description

Subcutaneous injection of Dose 1 of FE 999302 as a single dose.

Arm Title

Dose 2 of FE 999302

Arm Type

Experimental

Arm Description

Subcutaneous injection of Dose 2 of FE 999302 as a single dose.

Arm Title

Dose 3 of FE 999302

Arm Type

Experimental

Arm Description

Subcutaneous injection of Dose 3 of FE 999302 as a single dose.

Arm Title

250 μg OVITRELLE

Arm Type

Active Comparator

Arm Description

Subcutaneous injection of 250 μg of OVITRELLE. 0.5 mL as a single dose.

Arm Title

10,000 IU NOVAREL

Arm Type

Active Comparator

Arm Description

Subcutaneous injection of 10,000 IU NOVAREL. 1 mL as a single dose.

Intervention Type

Drug

Intervention Name(s)

FE 999302

Other Intervention Name(s)

recombinant hCG

Intervention Description

Subcutaneous injection as a single dose. 3 different doses

Intervention Type

Drug

Intervention Name(s)

Ovitrelle

Intervention Description

Subcutaneous injection as a single dose. 250 µg (0.5 mL)

Intervention Type

Drug

Intervention Name(s)

Novarel

Intervention Description

Subcutaneous injection as a single dose. 10,000 IU (1 mL)

Primary Outcome Measure Information:

Title

Number of metaphase II (MII) oocytes

Time Frame

On the day of oocyte retrieval (2 days after triggering)

Secondary Outcome Measure Information:

Title

Number of oocytes retrieved

Time Frame

On the day of oocyte retrieval (2 days after triggering)

Title

Number of fertilised (2 pronuclei) oocytes

Time Frame

On day 1 insemination (3 days after triggering)

Title

Number and quality of embryos on day 3 after oocyte retrieval

Time Frame

Day 3 after insemination (5 days after triggering)

Title

Number and quality of blastocysts on day 5 after oocyte retrieval

Time Frame

Day 5 after insemination (7 days after triggering)

Title

Serum hormone concentrations of progesterone

Time Frame

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

Title

Serum hormone concentrations of 17-OH-progesterone

Time Frame

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

Title

Serum hormone concentrations of estradiol

Time Frame

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

Title

Serum hormone concentrations of follicle stimulating hormone (FSH)

Time Frame

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

Title

Serum hormone concentrations of luteinising hormone (LH)

Time Frame

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

Title

Positive βhCG (positive serum βhCG test 13-15 days after transfer)

Time Frame

20-22 days after triggering

Title

Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer)

Time Frame

6-7 weeks after triggering

Title

Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)

Time Frame

6-7 weeks after triggering

Title

Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)

Time Frame

11-12 weeks after triggering

Title

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)

Time Frame

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

Title

Ovarian hyperstimulation syndrome (OHSS), overall and by timing, grade, and severity

Description

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.

Time Frame

≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS)

Title

Injection site reactions (redness, pain, itching, swelling, and bruising) assessed by the subject following administration of investigational medicinal product (IMP)

Time Frame

Immediately, 30 minutes, and 24 hours after injection

Title

Treatment-induced anti-hCG antibodies, overall as well as with neutralising capacity

Time Frame

Day of triggering up until 19-28 days after triggering

Title

Multi-fetal gestation

Time Frame