Effect of Metformin on Non PCO Women Undergoing IVF/ICSI
1 other identifier
interventional
400
1 country
1
Brief Summary
400 Patients will be randomly assigned into two groups after informed consent from every patient. They will be classified into 2 groups: Group A ( involves 200 patients ) will receive metformin 850 mg twice daily along the cycle of Intra-cytoplasmic sperm injection (ICSI) Group B ( involve 200 patients) will not receive metformin. They will undergo a cycle of ICSI. Primary outcome of this trial is to detect occurrence of Ovarian Hyper-stimulation Syndrome (OHSS) , while secondary outcomes include quality \& number of retrieved follicles fertilization rate ,ongoing pregnancy rate \& endometrial thickness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedStudy Start
First participant enrolled
July 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2020
CompletedMarch 8, 2024
March 1, 2024
4 months
July 22, 2020
March 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of OHSS
The number of cases of Ovarian Hyperstimulation Syndrome per cycle
4weeks
Secondary Outcomes (3)
The number of Mature retrieved eggs ( M-I) follicles .
2-4weeks
fertilization rate
4weeks
pregnancy rate
4 weeks
Study Arms (2)
metformin
ACTIVE COMPARATORGroup A ( involve 200 patients ) will receive metformin 850 mg twice daily along the cycle of ICSI
No Metformin
NO INTERVENTIONGroup B ( involve 200 patients) will not receive metformin
Interventions
Eligibility Criteria
You may qualify if:
- Patients subjected to IVF/ICSI aged 20-35 years with long agonist protocol
- history of infertility for at least two years (either primary or secondary)
- normal TSH and prolactin
You may not qualify if:
- Patients who used metformin in the past 3-months before study
- having medical problems such as kidney or liver diseases
- Severe endometriosis.
- hypothalamic amenorrhea.
- Severe male factor( patients with testicular biopsy or those with azoospermia).
- Associated uterine factor.
- IVF/ ICSI for sex selection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amal Kotb, MD
Beni-Suef University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
July 22, 2020
First Posted
July 28, 2020
Study Start
July 28, 2020
Primary Completion
November 27, 2020
Study Completion
November 27, 2020
Last Updated
March 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share