Recombinant Follicle-stimulating Hormone in Treatment for Infertility
- Conditions
- Female Infertility
- Interventions
- Drug: Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen
- Registration Number
- NCT05266924
- Lead Sponsor
- Bharat Serums and Vaccines Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 250
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Subject has indication ART using COS.
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Subject has regular menstrual cycle of 21-35 days.
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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
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Subject has an antral follicle count (AFC) of 10- 25, follicle ≤10 mm in diameter before ovarian stimulation
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Subject has a BMI ≥18 and <30 kg/m2
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Subject has results of clinical laboratory tests within normal reference range
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Subject and her partner are willing to provide written informed consent and comply
Exclusion Criteria Details Subject has history of >2 failed ART cycles
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Subject with history of any endocrine abnormality, with documented hormone levels outside the reference range, which are clinically relevant, at screening
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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
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Subject with documented polycystic ovarian syndrome (PCOS) at the time of screening
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Subject with only one ovary or ovarian abnormality (including endometrioma >10 mm; visible on USG), at screening
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Subject with documented severe endometriosis (American Society of Reproductive Medicine stage 3 or stage 4) or hydrosalpinx, at screening
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Subject with submucosal fibroids ≥5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation, at screening
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Subject with a history of extrauterine pregnancy within 3 months of screening
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Subject with history of poor response to gonadotropin treatment (retrieval of <4 oocytes) in the previous ART cycle
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Subject with history of ≥3 miscarriages, at any time prior to screening
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Subject who has tested positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C at screening
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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
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Subject with contraindications to the use of gonadotropins (e.g., tumours, undiagnosed vaginal bleeding, or ovarian cysts) or gonadotropin-releasing hormone (GnRH) antagonists
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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
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Subject with history of malignancy
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Subject who smokes or has stopped smoking within the last 3 months prior to screening
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Subject with history of alcohol or drug abuse within 12 months prior to screening
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Subject who has received any treatment listed below within 5 half-lives prior to screening:
- Any agent(s) known to affect ovulation (e.g., neuroleptics);
- Drugs known or suspected to be teratogenic in nature.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen 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 Reference group Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen Gonal-f Recombinant Human Follicle Stimulating Hormone
- Primary Outcome Measures
Name Time Method Number of oocytes retrieved Oocyte pick up - up to ~ 34 to 36 hours after human chorionic gonadotropin (hCG) administration Number of oocytes retrieved
- Secondary Outcome Measures
Name Time Method Ongoing Pregnancy rate 11±1 weeks after ET Ongoing pregnancy rate
Hormonal Investigation Day 6 Estradiol, Luteinizing, Progesterone, and inhibin b levels
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 Cycle cancellation rate
Clinical pregnancy rate 4 weeks after embryo transfer (ET) Clinical pregnancy rate
Total Doseof r-hFSH at end of stimulation up to 20 days Total dose of r-hFSH (in IU) required for ovarian stimulation;
Number of Days of r-hFSH stimulation at end of stimulation up to 20 days Number of days of r-hFSH stimulation
Number of subject Change in Dosage post Day 6 till end of stimulation up to 20 days Proportion of subjects requiring change in dose
Follicle size on Day 6 Day 6 Number of follicles with size \<11mm, Number of follicles with size 11- 14 mm, Number of follicles with size15 mm, Number of follicles with size16 mm, Number of follicles with size17 mm and Number of follicles with size ≥18 mm
Number of good quality embryos ET day (up to 8 weeks) Number of good quality embryos
Follicle size at HCG administration Day of hCG administration anytime upto 3 weeks Number of follicles with size \<11mm, Number of follicles with size 11- 14 mm, Number of follicles with size15 mm, Number of follicles with size16 mm, Number of follicles with size17 mm and Number of follicles with size ≥18 mm mm)
Endometrium thickness day 6 Endometrial thickness (mm)
Endometrium at HCG administration day of hCG injection (anytime upto 3 weeks) Endometrial thickness (mm)
Number of Matured oocytes Oocyte pick up ~ 34 to 36 hours after hCG administration Proportion of matured oocytes
Number of Adverse events Baseline, 1st day of stimulation, day 6 , end of stimulation up to 20 days, hCG administration, oocyte pick up ~ 34 to 36 hours after hCG administration, ET up to 8 weeks, clinical pregnancy (after 4 weeks of ET), ~12 weeks after ET Number of treatment-emergent adverse events (TEAE) reported
Specific adverse events Day 1 of Stimulation till ~12 weeks after ET The number of patients with ovarian hyperstimulation syndrome (OHSS) reported
Exploratory End of stimulation up to 20 days Ease of use of Pen - comparison of total score of Questionnaire to user of rhFSH pen
Evaluation of immunogenicity (antibody) of r-hFSH Baseline, 4 weeks and 12 weeks Evaluation of immunogenicity of r-hFSH, comparison of antibody titre against r-hFSH in both groups
Trial Locations
- Locations (1)
Om Research Center Om Surgical Center and Maternity Home
🇮🇳Varanasi, Uttar Pradesh, India
Om Research Center Om Surgical Center and Maternity Home🇮🇳Varanasi, Uttar Pradesh, India