Growth Hormone For Poor Ovarian Reserve Patients in ICSI... | NCT05602090

Studies
Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials

NCT05602090

Sponsor

Beni-Suef University

Status

Unknown status

Last Update Posted

Apr 28, 2023Actual

Enrollment

120Estimated

Phase

Phase 2Phase 3

Conditions

Poor Ovarian Reserve

Interventions

4 IU of recombinant GH (Somatotropin )

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Sep 4, 2023Estimated

Completion Date

Oct 30, 2023Estimated

First Submitted Date

Oct 27, 2022

First Submission Date that Met QC Criteria

Oct 27, 2022

First Posted Date

Nov 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2023

Last Update Posted Date

Apr 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
4 IU of recombinant GH (Somatotropin )	Drug	4 IU of recombinant GH	Growth Hormone adjuvant treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pregnancy rate	HCG positive	ICSI trial (1month)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Any known contraindications to the approved fertility drugs.
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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sara A Salem, MD	Contact	01272842226	02	sara_abdallah100@yahoo.com

Overall Officials

Name	Affiliation	Role
Beni-Suef University	Faculty of Medicine Beni-Suef University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni-suef university	Recruiting	Banī Suwayf	Beni Suweif Governorate	62521	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013006	Growth Hormone

Ancestor Terms

ID	Term
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

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