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

NCT03373149 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2020-05-27

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Riyadh Fertility and Reproductive Health center

    lead OTHER

Principal Investigators

  • Hisham S Elshaer, Prof. · Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health center

  • Usama M Fouda, Prof. · Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center

  • Mohammad Taymour, M.D, PhD · Lecturer of Obstetrics and Gynecology, Faculty of medicine,Cairo university. Consultant at Riyadh Fertility and Reproductive Health center

  • Ahmed A Wali, M.D, PhD · Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center

  • Fatma Faisel, M.D, PhD · Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2020-07-31
Completion
2020-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373149 on ClinicalTrials.gov