The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders

Phase 2

Not yet recruiting

• Conditions: Poor Responders
• Interventions: Drug: myo-inositol; Drug: Dehydroepiandrosterone; Drug: Somatropin

• Registration Number: NCT05900661
• Lead Sponsor: Beni-Suef University

Brief Summary

To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder

Detailed Description

Each patient will be subjected to:

Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.

Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.

Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .

For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.

The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection.

Study Timeline

• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-04
• Study First Posted: 2023-06-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-16
• Last Update Posted: 2023-07-18
• Study Start: 2023-07-30
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• 1-Infertile women who have one of the criteria of poor ovarian response as follows ;
• Antral follicle count less than 7
• Anti-Mullerian hormone level Less than 1.2 ng/ml 2- females with body mass index (BMI) from 19-25

Exclusion Criteria

1. Any endocrine or metabolic disorder such as polycystic ovary syndrome,
2. Hyperprolactinemia, diabetes and thyroid dysfunction.
3. Any pelvic pathology such as hydrosalpinx, uterine anomaly.
4. any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or Azoospermia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
myo-inositol	myo-inositol	will recive Inofolic (myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks
Dehydroepiandrosterone	Dehydroepiandrosterone	DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.
Somatropin	Somatropin	Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.

Primary Outcome Measures

Name	Time	Method
Number and maturity of oocytes retrieved	1 month	Number and maturity of oocytes retrieved (M1/M2)

Secondary Outcome Measures

Name	Time	Method
chemical pregnancy rate	1 month	hcg positive

Trial Locations

Locations (1)

Beni-suef university Hospital; 🇪🇬 Banī Suwayf, Beni Suef, Egypt