A comparative clinical trial to test efficacy and safety of 2 brands of highly purified follicle-stimulating hormone in subjects undergoing IVF

Phase 3

• Conditions: Infertility in female

• Registration Number: CTRI/2010/091/000852
• Lead Sponsor: Bharat Serums and Vaccines Limited

Brief Summary

1. This study is a randomised open label multi-centre trial to compare the efficacy and safety of 2 brands of highly purified follicle-stimulating hormone in subjects undergoing their first cycle of invitro fertilization with intracytoplasmic sperm injection (ICSI). The study is being conducted at 5 centres in India. The primary outcomes are total number of eggs, total number of mature oocytes retrieved, no. of HP FSH vials used, total days of FSH stimulation. The secondary outcomes are number of embryos cleaved, clinical pregnancy rate, incidence of severe OHSS - Grade IV to VI and cancellation rate.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

• Subjects undergoing first cycle of invitro fertilization with Intracytoplasmic sperm injection (ICSI)2.
• Subjects aged >18 and <35 years 3.
• Normogonadotrophic subjects with normal FSH and LH levels4.
• Semen parameters compatible with Intracytoplasmic sperm injection (ICSI) 5.
• Hysterosalpingography or hysteroscopy documenting a uterus consistent with expected normal function 6.
• Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality.

Exclusion Criteria

• Subjects > 35 years of age.2. Infertility attributable to severe endometriosis (grade III or IV) 3.
• Subjects with previous failed IVF or IVF with ICSI cycle 4.
• Pelvic pathology that would compromise invitro fertilization (IVF) success5.
• Tumors and malformation of sexual organs incompatible with pregnancy 6.
• Hypersensitivity to any trial product.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Total number of eggs 2. Total number of mature oocytes retrieved 3. No. of HP FSH vials used 4. Total days of FSH stimulation	End of study - 6 weeks

Secondary Outcome Measures

Name	Time	Method
1. Number of embryos cleaved 2. Clinical pregnancy rate 3. Incidence of severe OHSS - Grade IV to VI 4. Cancellation Rate	End of study - 6 weeks

Trial Locations

Locations (5)

Bavishi Fertility Institute; 🇮🇳 Ahmadabad, GUJARAT, India

Mandakini IVF Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Pulse Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Shanti Memorial Hospital; 🇮🇳 Udit, Nagar,, India

VAUNSHDHARA TEST TUBE BABY CENTRE; 🇮🇳 Nagpur, MAHARASHTRA, India

Bavishi Fertility Institute

🇮🇳Ahmadabad, GUJARAT, India

Dr. Himanshu Bavishi

Principal investigator

07926574901

drbavishi@ivfclinic.com