Concomitant CC and E2 Versus CC Alone in Ovulation Induction
Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial
1 other identifier
interventional
600
1 country
3
Brief Summary
The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2014
Longer than P75 for phase_4
3 active sites
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
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 28, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMarch 22, 2017
March 1, 2017
4.1 years
June 28, 2014
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
6-8 weeks gestational age
Secondary Outcomes (1)
Endometrial thickness on day of HCG administration
3 months
Other Outcomes (2)
Ovulation rate
3 months
Number of ovarian follicles ≥ 18 mm on day of HCG administration
3 months
Study Arms (2)
Clomiphene citrate-Estradiol group
ACTIVE COMPARATORWomen will receive clomiphene citrate and estradiol
Clomiphene citrate group
ACTIVE COMPARATORWomen will receive clomiphene citrate and placebo
Interventions
Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle)
Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)
Eligibility Criteria
You may qualify if:
- Infertile women with eugonadotrophic anovulation/oligoovulation.
- Unexplained infertility.
You may not qualify if:
- Age \< 20 or \> 35 years.
- Body mass index (BMI) \< 18.5 kg/m2 or \> 25 kg/m2.
- Presence of any infertility factor other than anovulation/oligoovulation.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Metabolic or hormonal abnormalities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111, Egypt
Private practice settings
Al Mansurah, Dakahlia Governorate, Egypt
Private practice settings
Mīt Ghamr, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed M Badawy, Prof
Mansoura University
- STUDY DIRECTOR
Maher E Kamel Elesawi, Dr
Mansoura University
- STUDY DIRECTOR
Mohamed S Abdelhafez, Dr
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 28, 2014
First Posted
July 10, 2014
Study Start
June 1, 2014
Primary Completion
July 1, 2018
Study Completion
August 1, 2018
Last Updated
March 22, 2017
Record last verified: 2017-03