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

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ClinicalTrials.gov Identifier: NCT03373149
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Growth hormone/HPuFSH/GnRH antagonist Drug: HPuFSH/GnRH antagonist Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Growth hormone/HPuFSH/GnRH antagonist
The patients receive growth hormone
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.


Active Comparator: HPuFSH/GnRH antagonist
Growth hormone is not used
Drug: 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.





Primary Outcome Measures :
  1. The number of participants who achieved a clinical pregnancy in a transfer cycle [ Time Frame: Five weeks after embryo transfer ]

Secondary Outcome Measures :
  1. The number of participants who achieved a ongoing pregnancy in a transfer cycle [ Time Frame: Eighteen weeks after embryo transfer ]


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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who responded poorly to high dose gonadotropin treatment in their first cycles (peak E ≤500 pg/mL, or retrieval of less than four oocytes).
  • Patients with age more than 40 years, bilateral antral follicle count less than 6
  • Serum anti-Müllerian hormone (AMH) less than 0.66 ng/ml

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373149


Contacts
Contact: Usama M Fouda, Prof. +201095401375 umfrfouda@yahoo.com

Locations
Egypt
Riyadh Fertility and Reproductive Health center Recruiting
Giza, Egypt
Contact: Usama M Fouda, Prof.    +201095401375    umfrfouda@yahoo.com   
Sponsors and Collaborators
Riyadh Fertility and Reproductive Health center
Investigators
Study Chair: Hisham S Elshaer, Prof. Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health center
Study Director: Usama M Fouda, Prof. Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Principal Investigator: 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

Publications:
Responsible Party: Riyadh Fertility and Reproductive Health center
ClinicalTrials.gov Identifier: NCT03373149     History of Changes
Other Study ID Numbers: Gh/poor responders
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Riyadh Fertility and Reproductive Health center:
IVF
Growth hormone
Poor responders

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Hormones
Prolactin Release-Inhibiting Factors
Chorionic Gonadotropin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents