Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response

Phase 2

• Conditions: Infertility, Female
• Interventions: Drug: Growth hormone/HPuFSH/GnRH antagonist; Drug: HPuFSH/GnRH antagonist

• Registration Number: NCT03373149
• Lead Sponsor: Riyadh Fertility and Reproductive Health center

Brief Summary

In this study, the investigators will assess the efficacy of growth hormone co-stimulation to GnRH antagonist regimen in poor responders to COH for IVF.

Detailed Description

To date, a limited number of studies have been performed in order to assess whether the addition of GH can improve the probability of pregnancy in poor responders undergoing ovarian stimulation for IVF. Moreover, the existing studies are underpowered and, thus, inconclusive.

In this study, the investigators will assess the efficacy of growth hormone co-stimulation to GnRH antagonist regimen in poor responders to COH for IVF.

Study Timeline

• Study Start: 2017-11-29
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-14
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-24
• Last Update Posted: 2020-05-27
• Primary Completion: 2020-07
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 228

Inclusion Criteria

• Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Growth hormone/HPuFSH/GnRH antagonist	Growth hormone/HPuFSH/GnRH antagonist	The patients receive growth hormone
HPuFSH/GnRH antagonist	HPuFSH/GnRH antagonist	Growth hormone is not used

Primary Outcome Measures

Name	Time	Method
The number of participants who achieved a clinical pregnancy in a transfer cycle	Five weeks after embryo transfer

Secondary Outcome Measures

Name	Time	Method
The number of participants who achieved a ongoing pregnancy in a transfer cycle	Eighteen weeks after embryo transfer

Trial Locations

Locations (1)

Riyadh Fertility and Reproductive Health center; 🇪🇬 Giza, Egypt