The Effect of Pretreatment With Dydrogesterone Vs Combined Estradiol Valerate and Dydrogestrone on Clinical Pregnancy Outcome of ICSI in PCOS Patients"
1 other identifier
interventional
500
0 countries
N/A
Brief Summary
To analyze the effect of pretreatment with dydrogesterone vs combined estradiol valerate and dydrogesterone on embryologic parameters, chemical and clinical pregnancy rates of ICSI in women with PCOS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2022
Shorter than P25 for early_phase_1
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
March 19, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedApril 14, 2022
April 1, 2022
11 months
March 19, 2022
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
chemical pregnancy rate
positive pregnancy test in serum or urine without ultrasound evidence of a gestational sac; expressed per100 embryo transfer cycles.
6 gestational weeks
Clinical pregnancy rate
u/s visualization of a gestational sac and embryonic pole with heart beat expressed per per100 embryo transfer cycles.
6 gestational weeks
Study Arms (2)
Dydrogesterone group
ACTIVE COMPARATORPretreatment with dydrogestrone (Duphaston, Abott Healthcare, Egypt) will be administered during the cycle preceding the ICSI cycle in a daily dose of 20 mg/ day starting 10 days before the presumed onset of menses
Dydrogesterone plus estradiol valerate group
ACTIVE COMPARATORwill receive dydrogestrone 10mg /day plus estradiol valerate 2 mg /d (white tablets of cycloprognova, Bayer Schering, Germany) for 10 days.
Interventions
Pretreatment with dydrogestrone (Duphaston, Abott Healthcare, Egypt) will be administered during the cycle preceding the ICSI cycle in a daily dose of 20 mg/ day starting 10 days before the presumed onset of menses
will receive dydrogestrone 10mg /day plus estradiol valerate 2 mg /d (white tablets of cycloprognova, Bayer Schering, Germany) for 10 days.
Eligibility Criteria
You may qualify if:
- age 18 to 35 years.
- BMI between 19 and 25 kg/square meter.
- AMH 3.5-6 ng/ml
- fresh or frozen embryo transfer
You may not qualify if:
- FSH more than 12 IU /L
- AFC- performed on day 3 of the cycle- less than 4
- Existence of hydrosalpinx on ultrasonography
- uterine disorders as that caused by uterine fibroids.
- All male partners should have normal semen parameters .
- Women with more than 20 oocytes
- Any sign of early onset OHSS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Mohammed Yehia
CONTACT
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 19, 2022
First Posted
March 29, 2022
Study Start
May 1, 2022
Primary Completion
April 1, 2023
Study Completion
May 1, 2023
Last Updated
April 14, 2022
Record last verified: 2022-04