Microflare Protocol in Poor Responders

Phase 4

Completed

• Conditions: Female Infertility Due to Diminished Ovarian Reserve
• Interventions: Drug: Growth hormone (Norditropin, Novo nordisk)

• Registration Number: NCT02185326
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders

Detailed Description

The microflare as a method of down regulation protocol can be used to prepare the females suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying to outline its effect on the clinical pregnancy rate as a main primary outcome, and to compare its use with the addition of growth hormone to the same protocol.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-06
• Study First Posted: 2014-07-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

Inclusion Criteria

• females fulfilling the criteria of the ESHRE consensus 2011:

At least two of the following three features must be present:

(i) Advanced maternal age (≥40 years) or any other risk factor for POR; (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).

Exclusion Criteria

• women who suffer from any other cause of infertility other than poor ovarian reserve
• refusal of the patient to consent for using her data in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microflare and growth hormone	Growth hormone (Norditropin, Novo nordisk)	the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rates	15 months

Trial Locations

Locations (1)

Kasr el aini hospital; 🇪🇬 Cairo, Egypt