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

A prospective, multicenter, randomized, open, comparative clinical trial to test 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).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000852

Enrollment

100

Registered

2010-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Highly Purified Follicle Stimulating Hormone - Test drug: 2 to 4 vials of 75 IU will be administered subcutaneously per day for about 8 - 12 days. Control Intervention1: Highly Purified

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 levels 4. 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

Exclusion criteria: 1. 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) success 5. Tumors and malformation of sexual organs incompatible with pregnancy 6. Hypersensitivity to any trial product

Design outcomes

Primary

Measure	Time frame
1. Total number of eggs 2. Total number of mature oocytes retrieved 3. No. of HP FSH vials used 4. Total days of FSH stimulationTimepoint: End of study - 6 weeks	—

Secondary

Measure	Time frame
1. Number of embryos cleaved 2. Clinical pregnancy rate 3. Incidence of severe OHSS - Grade IV to VI 4. Cancellation RateTimepoint: End of study - 6 weeks	—

Countries

India

Contacts

Public ContactNaju Turakhia

map@parihar.com022-25224845, 25227539

Outcome results