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

Beni-Suef University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Poor Responders

Treatments: Drug: Dehydroepiandrosterone; Drug: myo-inositol; Drug: Somatropin

Study type: Interventional

Funder types: Other

Identifiers

NCT05900661

poor ovarian responders

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

myo-inositol

Experimental group

Description:

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

Treatment:

Drug: myo-inositol

Somatropin

Experimental group

Description:

Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.

Treatment:

Drug: Somatropin

Dehydroepiandrosterone

Experimental group

Description:

DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.

Treatment:

Drug: Dehydroepiandrosterone