Human Chorionic Gonadotrophin & Trigger

Cairo University200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Ovulation Disorder

Interventions

Human chorionic gonadotrophinDRUG

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 aloneDRUG

clomiphene citrate alone without hCG trigger

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

faculty of medicine , Cairo University

Cairo, Cairo Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

chemical pregnancy

A positive urine pregnancy test done 7 days after missing the period

Time frame: 1 year

Clinical pregnancy

demonstration of a fetal heart beat on transvaginal ultrasound between 6 and 7 weeks of gestation.

Time frame: 1 year

Central Contacts

Waleed EL-khayat, M.D.

CONTACT

01005135542 waleed_elkhyat@yahoo.com

Data from ClinicalTrials.gov

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