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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03373149
• Other study ID #: Gh/poor responders
• Status: Recruiting
• Phase: Phase 2
• Start date: November 29, 2017
• Est. completion date: November 2020

Study information

• Verified date: May 2020
• Source: Riyadh Fertility and Reproductive Health center
• Contact: Usama M Fouda, Prof.
• Phone: +201095401375
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: November 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 42 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Growth hormone/HPuFSH/GnRH antagonist
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.
• HPuFSH/GnRH antagonist
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.

Locations

Country	Name	City	State
Egypt	Riyadh Fertility and Reproductive Health center	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Fertility and Reproductive Health center

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants who achieved a clinical pregnancy in a transfer cycle		Five weeks after embryo transfer
Secondary	The number of participants who achieved a ongoing pregnancy in a transfer cycle		Eighteen weeks after embryo transfer