Recombinant Follicle-stimulating Hormone in Treatment for Infertility

NCT05266924 | Unknown Phase 3

• 1 other identifier: BSV_rhFSH_20_09
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized multi-centre, assessor-blind, parallel-group study to be conducted in 250 women in the age group of 20 to 39 years (both inclusive), who are indicated to undergo COS as part of assisted reproductive technology (ART). The participant will receive r-hFSH, fixed-dose for 5 days, and day 6 onwards the dose may be adjusted for a single cycle of COS followed by ART procedures, and post-ART follow-up for ongoing pregnancy. The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  Number of oocytes retrieved

  Oocyte pick up - up to ~ 34 to 36 hours after human chorionic gonadotropin (hCG) administration

Secondary Outcomes (17)

• Clinical pregnancy rate

  4 weeks after embryo transfer (ET)

• Ongoing Pregnancy rate

  11±1 weeks after ET

• Cycle cancellation rate

  at Stimulation phase up to 20 days, oocyte pick up up to ~ 34 to 36 hours after hCG administration, ET anytime up to 8 weeks

• Total Doseof r-hFSH

  at end of stimulation up to 20 days

• Number of Days of r-hFSH stimulation

  at end of stimulation up to 20 days

Study Arms (2)

Test group

EXPERIMENTAL

Foligraf 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen Follicle Stimulating Hormone (Human Recombinant) manufactured by Bharat Serums and Vaccines Ltd

Drug: Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen

Reference group

ACTIVE COMPARATOR

Gonal-f Recombinant Human Follicle Stimulating Hormone

Drug: Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen

Interventions

Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen DRUG

fixed-dose of 225 IU/day, subcutaneous (SC), daily, for 5 days. further dosage will be adjusted till adequate follicular development.

Also known as: Foligraf, Gonal-f

Reference group; Test group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has indication ART using COS.
• Subject has regular menstrual cycle of 21-35 days.
• Subject has one of the following:
• FSH level \<10 IU/L and Estradiol levl \<80 pg/mL at day 2 or 3
• Anti-mullerian hormone (AMH) level between 1 to 3.5 ng/mL during the menstrual cycle
• Subject has an antral follicle count (AFC) of 10- 25, follicle ≤10 mm in diameter before ovarian stimulation
• Subject has a BMI ≥18 and \<30 kg/m2
• Subject has results of clinical laboratory tests within normal reference range
• Subject and her partner are willing to provide written informed consent and comply

You may not qualify if:

• Subject with history of any endocrine abnormality, with documented hormone levels outside the reference range, which are clinically relevant, at screening
• Subject with a history of ovarian hyper-response (i.e., previous COS cycle with \>25 follicles of ≥11 mm in diameter on USG) or OHSS
• Subject with documented polycystic ovarian syndrome (PCOS) at the time of screening
• Subject with only one ovary or ovarian abnormality (including endometrioma \>10 mm; visible on USG), at screening
• Subject with documented severe endometriosis (American Society of Reproductive Medicine stage 3 or stage 4) or hydrosalpinx, at screening
• Subject with submucosal fibroids ≥5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation, at screening
• Subject with a history of extrauterine pregnancy within 3 months of screening
• Subject with history of poor response to gonadotropin treatment (retrieval of \<4 oocytes) in the previous ART cycle
• Subject with history of ≥3 miscarriages, at any time prior to screening
• Subject who has tested positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C at screening
• Subject known to be allergic, hypersensitive, or intolerant to any of the preparations of r hFSH or its excipients, that will be used in the study
• Subject with contraindications to the use of gonadotropins (e.g., tumours, undiagnosed vaginal bleeding, or ovarian cysts) or gonadotropin-releasing hormone (GnRH) antagonists
• Subject with a history of epilepsy, thrombophilia, cardiovascular, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease, or any active infection, requiring treatment which at the investigator's discretion might interfere with the study
• Subject with history of malignancy
• Subject who smokes or has stopped smoking within the last 3 months prior to screening

Sponsors & Collaborators

• Bharat Serums and Vaccines Limited: lead

Study Sites (1)

Om Research Center Om Surgical Center and Maternity Home

Varanasi, Uttar Pradesh, 221007, India

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Solutions; Injections; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessor including the investigator, outcoume assessor (sonography, embyrologist) shall be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Randomized, Parallel-group, Multi-Center, Assessor-blind Phase 3 Study.

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: March 4, 2022
• Study Start: July 23, 2022
• Primary Completion: August 31, 2023
• Study Completion: November 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)