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Role of Intermittent Fasting Before ICSI

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intermittent fasting 4 months before ICSI
Sponsored by
Aljazeera Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women with infertility

Exclusion Criteria:

  • ovarian factor or uterine factor of infertility

Sites / Locations

  • Algazeerah and helwan universityRecruiting
  • Algazeerah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intermittent fasting

No intermittent fasting

Arm Description

intermittent fasting before ICSI

Usual diet

Outcomes

Primary Outcome Measures

the number of women who will have positive pregnancy test after ICSI
The women who will get pregnant after ICSI with positive pregnancy test

Secondary Outcome Measures

Full Information

First Posted
November 29, 2019
Last Updated
January 24, 2020
Sponsor
Aljazeera Hospital
Collaborators
National Research Centre, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04184167
Brief Title
Role of Intermittent Fasting Before ICSI
Official Title
Role of Intermittent Fasting Before Intracytoplasmic Sperm Injection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
September 2, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
Collaborators
National Research Centre, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
intermittent fasting could have a role in infertility
Detailed Description
intermittent fasting could have a role in infertility and could adjust the body weight before ICSI

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intermittent fasting
Arm Type
Active Comparator
Arm Description
intermittent fasting before ICSI
Arm Title
No intermittent fasting
Arm Type
Placebo Comparator
Arm Description
Usual diet
Intervention Type
Other
Intervention Name(s)
intermittent fasting 4 months before ICSI
Intervention Description
women will start intermittent fasting before starting ICSI by 4 months
Primary Outcome Measure Information:
Title
the number of women who will have positive pregnancy test after ICSI
Description
The women who will get pregnant after ICSI with positive pregnancy test
Time Frame
within 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
infertile women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with infertility Exclusion Criteria: ovarian factor or uterine factor of infertility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Organizational Affiliation
Algezeera hospitaland National Research Centre ,Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Algazeerah and helwan university
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Facility Name
Algazeerah
City
Giza
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master

12. IPD Sharing Statement

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Role of Intermittent Fasting Before ICSI

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