Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials

NCT05602090 | Unknown Phase 2

• 1 other identifier: FMBSUREC/01022022/Hemida
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Poor Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  HCG positive

  ICSI trial (1month)

Study Arms (2)

Growth Hormone adjuvant treatment

EXPERIMENTAL

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.

Drug: 4 IU of recombinant GH (Somatotropin )

control

NO INTERVENTION

standard controlled ovarian stimulation

Interventions

4 IU of recombinant GH (Somatotropin ) DRUG

4 IU of recombinant GH

Also known as: (Somatotropin )

Growth Hormone adjuvant treatment

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• According to Bologna criteria (((at least two )))of the following features must be present:
• Advanced maternal age (40years).
• A previous poor ovarian response with 3 oocytes retrieved after conventional stimulation
• An abnormal ovarian reserve test (ORT)
• antral follicle count (AFC)\<7 or
• anti-Müllerian hormone (AMH)\<1.1ng/ml.

You may not qualify if:

• Any known contraindications to the approved fertility drugs.
• Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment)
• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

RECRUITING

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Beni-Suef University

  Faculty of Medicine Beni-Suef University

  STUDY CHAIR

Central Study Contacts

Sara A Salem, MD

CONTACT

01272842226; sara_abdallah100@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: February 1, 2022
• Primary Completion: September 4, 2023
• Study Completion: October 30, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)