Human Chorionic Gonadotrophin & Trigger

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02264847

Enrollment

200

Registered

2014-10-15

Start date

2014-10-31

Completion date

2017-05-31

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovulation Disorder

Keywords

Clomiphene Citrate, Ovulation trigger, Human chorionic gonadotrophin

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.

Interventions

DRUGclomiphene citrate alone

clomiphene citrate alone without hCG trigger

DRUGHuman 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactWaleed EL-khayat, M.D.

waleed_elkhyat@yahoo.com01005135542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026