Trial | NCT03373149  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    somatropin cetrorelix ...

  • Study Participants

    228
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.
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 Started
Nov 29
2017
Primary Completion
Jul 31
2020
Anticipated
Study Completion
Nov 30
2020
Anticipated
Last Update
May 27
2020

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.

Growth hormone/HPuFSH/GnRH antagonist Experimental

The patients receive growth hormone

HPuFSH/GnRH antagonist Active Comparator

Growth hormone is not used

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

-
No Results Posted