A comparative clinical trial to test efficacy and safety of 2 brands of highly purified human menopausal gonadotropins in subjects undergoing their first cycle of IVF

A prospective, multicenter, randomized, open, comparative clinical trial to test efficacy and safety of 2 brands of highly purified human menopausal gonadotropins 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/2009/091/000854

Enrollment

100

Registered

2010-06-17

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 human menopausal gonadotropin - 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 &#8804; 35 years 3. BMI between 18 and 30 kg/m2 4. subjects with normal FSH and LH levels 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. Polycystic ovary disease 5.Undiagnosed vaginal bleeding 6. Tumors and malformation of sexual organs incompatible with pregnancy

Design outcomes

Primary

Measure	Time frame
1. Total number of eggs 2. Total number of mature oocytes retrieved 3. No. of HP HMG vials used 4. Total days of HMG stimulation Timepoint: 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. Cycle Cancellation Rate Timepoint: 6 weeks	—

Countries

India

Contacts

Public ContactNaju Turakhia

Mandakini IVF Centre

map@parihar.com022-25224845

Outcome results