Clinical trial NCT03373149: Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
Official title: Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility, Female
Keywords: IVF
Growth hormone
Poor responders
Lead sponsor: Riyadh Fertility and Reproductive Health center
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 228
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: The number of participants who achieved a clinical pregnancy in a transfer cycle
timeFrame: Five weeks after embryo transfer
Secondary outcomes:
measure: The number of participants who achieved a ongoing pregnancy in a transfer cycle
timeFrame: Eighteen weeks after embryo transfer
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Riyadh Fertility and Reproductive Health center
Study officials:
affiliation: Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health center
name: Hisham S Elshaer, Prof.
role: STUDY_CHAIR
affiliation: Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
name: Usama M Fouda, Prof.
role: STUDY_DIRECTOR
affiliation: Lecturer of Obstetrics and Gynecology, Faculty of medicine,Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
name: Mohammad Taymour, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
name: Ahmed A Wali, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
name: Fatma Faisel, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eftekhar M, Aflatoonian A, Mohammadian F, Eftekhar T. Adjuvant growth hormone therapy in antagonist protocol in poor responders undergoing assisted reproductive technology. Arch Gynecol Obstet. 2013 May;287(5):1017-21. doi: 10.1007/s00404-012-2655-1. Epub 2012 Dec 4.
citation: Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.