Current partner codePEPTIDESDE

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

Status

Unknown

Phase

Phase 2 / Phase 3

Enrollment

300

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

myo-inositol

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 produced by a Lo.Li pharma international ,Rome.Italy .

DRUG

Somatropin

growth hormone 2:Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.

DRUG

Dehydroepiandrosterone

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

Timeline

From registration to results.

  1. First posted

    Jun 12, 2023

  2. Study start

    Jul 30, 2023

  3. Primary completion

    Sep 30, 2023

  4. Study completion

    Sep 30, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Jul 18, 2023

Outcomes

What the study measures.

Primary outcomes

Number and maturity of oocytes retrieved

Time frame · 1 month

Number and maturity of oocytes retrieved (M1/M2)

Secondary outcomes

chemical pregnancy rate

Time frame · 1 month

hcg positive

Eligibility

Who can take part.

Minimum age
25 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.