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Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials

Phase 2
Recruiting
Conditions
Poor Ovarian Reserve
Interventions
Drug: 4 IU of recombinant GH (Somatotropin )
Registration Number
NCT05602090
Lead Sponsor
Beni-Suef University
Brief Summary

Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor ovarian Reserve Patients

Detailed Description

To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
120
Inclusion Criteria

According to Bologna criteria (((at least two )))of the following features must be present:

  1. Advanced maternal age (40years).

  2. A previous poor ovarian response with 3 oocytes retrieved after conventional stimulation

  3. An abnormal ovarian reserve test (ORT)

    • antral follicle count (AFC)<7 or
    • anti-Müllerian hormone (AMH)<1.1ng/ml.
Exclusion Criteria
  1. Any known contraindications to the approved fertility drugs.
  2. Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment)

4- Hydrosalpinx 5- Uterine malformations or abnormal uterine cavity. 6- Basal FSH more than 17 IU. 7- Abnormal karyotyping 8- Partner with severe male factor 9- Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Growth Hormone adjuvant treatment4 IU of recombinant GH (Somatotropin )Growth hormone in this trial will use 4 IU of recombinant GH (Somatotropin, ) by day after day subcutaneous injection for 6 weeks before starting cycle. And on start day of induction ( Day 2 to 3) until the day of the human chorionic gonadotropin (hCG) trigger.
Primary Outcome Measures
NameTimeMethod
pregnancy rateICSI trial (1month)

HCG positive

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Beni-suef university

🇪🇬

Banī Suwayf, Beni Suef, Egypt

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