Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials

NCT ID: NCT05602090

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-10-30

Brief Summary

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

Detailed Description

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

Conditions

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Poor Ovarian Reserve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Growth Hormone adjuvant treatment

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.

Group Type EXPERIMENTAL

4 IU of recombinant GH (Somatotropin )

Intervention Type DRUG

4 IU of recombinant GH

control

standard controlled ovarian stimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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4 IU of recombinant GH (Somatotropin )

4 IU of recombinant GH

Intervention Type DRUG

Other Intervention Names

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(Somatotropin )

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beni-Suef University

Role: STUDY_CHAIR

Faculty of Medicine Beni-Suef University

Locations

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Beni-suef university

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sara A Salem, MD

Role: CONTACT

01272842226 ext. 02

Facility Contacts

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Beni Suef University

Role: primary

082 2318605 ext. 2

Other Identifiers

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FMBSUREC/01022022/Hemida

Identifier Type: -

Identifier Source: org_study_id

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