Long Protocol and Growth Hormone in Poor Responders

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: Growth hormone

• Registration Number: NCT02338206
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Study Start: 2015-03
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Study Completion: 2017-11-15
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Poor responder females are those who posses two out of these three criteria:
• Female age ≥40 years
• Females who have at least one previous cancelled IVF cycle
• POR according to AFC ≤ 5 or low AMH value.

Exclusion Criteria

• Females over 45 years
• Females with FSH more than 20 IU/l
• Females with previous ovarian surgery
• Females suffering from causes of infertility other than poor ovarian response
• Females refusing to be enrolled in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long + Growth hormone	Growth hormone	Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.

Primary Outcome Measures

Name	Time	Method
Live birth rate	12 months	Fresh, Frozen, Cumulative

Trial Locations

Locations (1)

Kasr el aini hospital; 🇪🇬 Cairo, Egypt