Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials

Poor Ovarian Reserve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602090
• Other study ID #: FMBSUREC/01022022/Hemida
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2023
• Source: Beni-Suef University
• Contact: Sara A Salem, MD
• Phone: 01272842226
• Email: sara_abdallah100[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 30, 2023
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Poor Ovarian Reserve

Intervention

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

Locations

Country	Name	City	State
Egypt	Beni-suef university	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate	HCG positive	ICSI trial (1month)