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

NCT03373149 | Unknown Phase 2 DMC

• 1 other identifier: Gh/poor responders
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

IVF; Growth hormone; Poor responders

Outcome Measures

Primary Outcomes (1)

• The number of participants who achieved a clinical pregnancy in a transfer cycle

  Five weeks after embryo transfer

Secondary Outcomes (1)

• The number of participants who achieved a ongoing pregnancy in a transfer cycle

  Eighteen weeks after embryo transfer

Study Arms (2)

Growth hormone/HPuFSH/GnRH antagonist

EXPERIMENTAL

The patients receive growth hormone

Drug: Growth hormone/HPuFSH/GnRH antagonist

HPuFSH/GnRH antagonist

ACTIVE COMPARATOR

Growth hormone is not used

Drug: HPuFSH/GnRH antagonist

Interventions

Growth hormone/HPuFSH/GnRH antagonist DRUG

Growth hormone (Somatropin, Sedico, Egypt) \[4 IU/day\] and highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) \[300 IU/day\] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2). GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration.

Growth hormone/HPuFSH/GnRH antagonist

HPuFSH/GnRH antagonist DRUG

Highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) \[300 IU/day\] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2). GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration.

HPuFSH/GnRH antagonist

Eligibility Criteria

• Age: 35 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Riyadh Fertility and Reproductive Health center: lead

Study Sites (1)

Riyadh Fertility and Reproductive Health center

Giza, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 23208461 BACKGROUND

• 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.

  PMID: 34808697 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Hisham S Elshaer, Prof.

  Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health center

  STUDY CHAIR

• Usama M Fouda, Prof.

  Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center

  STUDY DIRECTOR

• Mohammad Taymour, M.D, PhD

  Lecturer of Obstetrics and Gynecology, Faculty of medicine,Cairo university. Consultant at Riyadh Fertility and Reproductive Health center

  PRINCIPAL INVESTIGATOR

• Ahmed A Wali, M.D, PhD

  Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center

  PRINCIPAL INVESTIGATOR

• Fatma Faisel, M.D, PhD

  Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Usama M Fouda, Prof.

CONTACT

+201095401375; umfrfouda@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 14, 2017
• Study Start: November 29, 2017
• Primary Completion: July 1, 2020
• Study Completion: November 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)