A clinical trial to study the effects of two different protocols of cetrorelix injection timings in IUI cycles in infertile women

Completed

• Conditions: Infertility

• Registration Number: CTRI/2014/12/005289
• Lead Sponsor: Not applicable

Brief Summary

This study is a randomized, open label, parallel group, three-arm controlled clinical trial in which the efficacy of two different regimens of GnRH antagonist i.e., Cetrorelix, in fixed and flexible regimens, was evaluated in clomiphene - gonadotropin induced controlled ovulation and intrauterine insemination cycles at All India Institute of Medical Sciences, New Delhi. The primary outcomes were premature luteinization rate and ovulation rates. The secondary outcomes were pregnancy rates, effect on endometrial thickness, effect on hormonal profiles, cycle cancellation rates and adverse effects like OHSS and multiple pregnancies.

Dosages of drug –

- Group I-Fixed day group (n =15 ) :  Clomiphene 50 mg/d orally will be given on day 2 to 6 of menstrual cycle  + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that +  Cetrorelix  0.25mg s/c from day 8 + hCG 10,000 IU (more than 18 mm  follicle) + IUI after 34-38 hours.

- Group 2-Flexible day group (n= 15 ) :  Clomiphene 50mg/d orally will be given on day 2 to 6 of menstrual cycle  + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that + Cetrorelix 0.25mg s/c @ follicle size ≥ 14 mm or  if LH > 10 IU/L +  hCG 10,000 IU (more than 18 mm follicle) + IUI after 34-38 hours.

- Group 3-control group (n=15 ) :  Clomiphene 50mg/d orally will be given on day 2 to 6 of menstrual cycle  + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that +  hCG 10,000 (more than 18 mm follicle) + IUI after 34-38 hours.

Duration of treatment – Maximum of three cycles per patient.

Investigation specifically related to projects- serum estradiol , serum LH, Serum progestrone

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-09
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

1)Unexplained infertility; 2)Mild male factor infertility; 3)Ovulation dysfunction infertility with previously failed induction with letrozole or clomiphene; 4)At least one patent fallopian tube; 5)BMI 18.5–29.9 kg/m2 6)Euthyroid state 7)No associated medical problems like diabetes mellitus or Hypertension or Drug allergies.

Exclusion Criteria

1)Severe male factor infertility; 2)Stage III or IV endometriosis; 3)Tubal Factor Infertility; 4)baseline FSH >12 IU/L; 5)Less than four antral follicles per ovary.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Ovulation rates	1. If LH more than 10 mIU/ml and Progesterone more than 2ng/ml on day 10 and/or day 12 of menstrual cycle | 2. Documented by transvaginal ultrasound after 36 hours of ovulation trigger
1.Premature luteinization rate	1. If LH more than 10 mIU/ml and Progesterone more than 2ng/ml on day 10 and/or day 12 of menstrual cycle | 2. Documented by transvaginal ultrasound after 36 hours of ovulation trigger

Secondary Outcome Measures

Name	Time	Method
1.Pregnancy rate	2.Endometrial thickness

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

Prof Alka Kriplani

Principal investigator

01126594933

kriplanialka@gmail.com