Human Chorionic Gonadotrophin & Trigger

Study Overview
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Brief Summary
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In women being treated with medicines to help eggs to grow (called ovulation induction), The investigators wish to know whether adding medicines (called ovulation triggers) that help to release the egg (ovulation) would lead to more women having babies without causing harm compared with not giving them ovulation triggers.

Detailed Description
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Women will be treated with clomiphene citrate to help eggs to develop to additionally receive a medicine (urinary hCG) to trigger their release or to receive no additional treatment. the investigators tried to determine the benefits and harms of administering an ovulation trigger to anovulatory women receiving treatment with ovulation-inducing agents in comparison with spontaneous ovulation following ovulation induction. so we will have comparison between 2 groups, group 1 will receive clomiphene citrate and trigger ovulation by human chorionic gonadotrophin and group 2 will receive clomiphene citrate with no drug to trigger ovulation.

Official Title
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Trigger or Not to Trigger? : An Answer for an Old Question

Conditions
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Ovulation Disorder

Intervention / Treatment
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* Drug: Human chorionic gonadotrophin
* Drug: clomiphene citrate alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normoprolactinemic and normogonadotropic (WHO class II ovarian dysfunction ) Primary infertility with oligomenorrhea (bleeding intervals between 35 days and 6 months) or amenorrhea (bleeding interval more than 6 months) Age 18-40 years Duration of primary infertility more than2 years No history of ovulation induction treatment No history of thyroid disease Normal results on hysterosalpingogram Husband with normal semen analysis - Exclusion Criteria: Ovarian cyst Endometrioma Liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clomiphene citrate plus hCG<br>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<br>* 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.<br>* Other names: hCG;|
| Active Comparator: Clomiphene Citrate alone<br>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<br>* clomiphene citrate alone without hCG trigger<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rate | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemical pregnancy | A positive urine pregnancy test done 7 days after missing the period | 1 year | 
| Clinical pregnancy | demonstration of a fetal heart beat on transvaginal ultrasound between 6 and 7 weeks of gestation. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clomiphene Citrate, Ovulation trigger, Human chorionic gonadotrophin