Human Chorionic Gonadotrophin & Trigger

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Ovulation Disorder

Treatments: Drug: Human chorionic gonadotrophin; Drug: clomiphene citrate alone

Study type: Interventional

Funder types: Other

Identifiers

NCT02264847

5102014

A5102014 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Clomiphene citrate plus hCG

Active Comparator group

Description:

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.

Treatment:

Drug: Human chorionic gonadotrophin

Clomiphene Citrate alone

Active Comparator group

Description:

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.

Treatment:

Drug: clomiphene citrate alone