NCT04184167

Brief Summary

intermittent fasting could have a role in infertility

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

November 29, 2019

Last Update Submit

January 24, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • the number of women who will have positive pregnancy test after ICSI

    The women who will get pregnant after ICSI with positive pregnancy test

    within 6 months

Study Arms (2)

intermittent fasting

ACTIVE COMPARATOR

intermittent fasting before ICSI

Other: intermittent fasting 4 months before ICSI

No intermittent fasting

PLACEBO COMPARATOR

Usual diet

Other: intermittent fasting 4 months before ICSI

Interventions

intermittent fasting 4 months before ICSIOTHER

women will start intermittent fasting before starting ICSI by 4 months

No intermittent fastingintermittent fasting

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertile women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with infertility

You may not qualify if:

  • ovarian factor or uterine factor of infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Algazeerah and helwan university

Giza, Egypt

RECRUITING

Algazeerah

Giza, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 3, 2019

Study Start

December 2, 2019

Primary Completion

September 2, 2020

Study Completion

October 1, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

EG(2)