Human Chorionic Gonadotrophin & Trigger
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|ClinicalTrials.gov Identifier: NCT02264847|
Recruitment Status : Unknown
Verified February 2017 by Waleed El-khayat, Cairo University.
Recruitment status was: Recruiting
First Posted : October 15, 2014
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ovulation Disorder||Drug: Human chorionic gonadotrophin Drug: clomiphene citrate alone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Trigger or Not to Trigger? : An Answer for an Old Question|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||May 2017|
Active Comparator: 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.
Drug: 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.
Other Name: hCG
Active Comparator: 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.
Drug: clomiphene citrate alone
clomiphene citrate alone without hCG trigger
- Ovulation rate [ Time Frame: 1 year ]
Collapse of the leading follicle with irregular shape, Appearance of the corpus luteum with diffuse internal echoes. Presence of fluid in the pouch of Douglas or hyperechoic endometrium were taken as supporting features.
Serum progesterone levels of more than 10 ng/mL were considered to be evidence of ovulation.
- chemical pregnancy [ Time Frame: 1 year ]A positive urine pregnancy test done 7 days after missing the period
- Clinical pregnancy [ Time Frame: 1 year ]demonstration of a fetal heart beat on transvaginal ultrasound between 6 and 7 weeks of gestation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264847
|Contact: Waleed EL-khayat, M.D.||01005135542 ext +email@example.com|
|faculty of medicine , Cairo University||Recruiting|
|Cairo, Egypt, 12311|
|Contact: Waleed M El-khayat, M.D. 0105135542 ext +2 firstname.lastname@example.org|
|Contact: Waleed El-khayat, M.D. 01005135542 ext +2 email@example.com|
|Principal Investigator: Waleed M El-Khayat, M.D.|
|Principal Investigator:||Waleed El-khyatat, M.D.||Cairo University|