Human Chorionic Gonadotrophin & Trigger

Phase 3

• Conditions: Ovulation Disorder
• Interventions: Drug: clomiphene citrate alone; Drug: Human chorionic gonadotrophin

• Registration Number: NCT02264847
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-04
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-08
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Normoprolactinemic and normogonadotropic (WHO class II ovarian dysfunction )

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

1. Ovarian cyst
2. Endometrioma
3. Liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clomiphene Citrate alone	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 plus hCG	Human chorionic gonadotrophin	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.

Primary Outcome Measures

Name	Time	Method
Ovulation rate	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

faculty of medicine , Cairo University; 🇪🇬 Cairo, Egypt