Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials

Beni-Suef University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Poor Ovarian Reserve

Treatments: Drug: 4 IU of recombinant GH (Somatotropin )

Study type: Interventional

Funder types: Other

Identifiers

NCT05602090

FMBSUREC/01022022/Hemida

Details and patient eligibility

About

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

Full description

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

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Growth Hormone adjuvant treatment

Experimental group

Description:

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.

Treatment:

Drug: 4 IU of recombinant GH (Somatotropin )

control

No Intervention group

Description:

standard controlled ovarian stimulation