Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2014-10-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Clomiphene citrate plus hCG
Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response could be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size . Women will receive 5,000 IU human chorionic gonadotrophin trigger in the morning between 9 and 10 a.m. and the couple will be advised to have intercourse the following night, about 36 hours later.
Human chorionic gonadotrophin
Once a follicle reached more than 18 mm in size,women assigned to group (1) received 5,000 IU hCG trigger in the morning between 9 and 10 a.m. and the couple were advised to have intercourse the following night, about 36 hours later.
Clomiphene Citrate alone
Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response will be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size , the women will be advised to have intercourse frequently over the next few days.
clomiphene citrate alone
clomiphene citrate alone without hCG trigger
Interventions
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Human chorionic gonadotrophin
Once a follicle reached more than 18 mm in size,women assigned to group (1) received 5,000 IU hCG trigger in the morning between 9 and 10 a.m. and the couple were advised to have intercourse the following night, about 36 hours later.
clomiphene citrate alone
clomiphene citrate alone without hCG trigger
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Primary infertility with oligomenorrhea (bleeding intervals between 35 days and 6 months) or amenorrhea (bleeding interval more than 6 months)
3. Age 18-40 years
4. Duration of primary infertility more than2 years
5. No history of ovulation induction treatment
6. No history of thyroid disease
7. Normal results on hysterosalpingogram
8. Husband with normal semen analysis
\-
Exclusion Criteria
2. Endometrioma
3. Liver disease
18 Years
40 Years
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Waleed El-khayat
Assistant Professor of Obstetrics & Gynecology
Principal Investigators
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Waleed El-khyatat, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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faculty of medicine , Cairo University
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.
Other Identifiers
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A5102014
Identifier Type: OTHER
Identifier Source: secondary_id
5102014
Identifier Type: -
Identifier Source: org_study_id
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