Human Chorionic Gonadotrophin & Trigger

Ovulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02264847
• Other study ID #: 5102014
• Secondary ID: A5102014
• Status: Recruiting
• Phase: Phase 3
• First received: October 4, 2014
• Last updated: February 7, 2017
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: February 2017
• Source: Cairo University
• Contact: Waleed EL-khayat, M.D.
• Phone: 01005135542
• Email: waleed_elkhyat[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovulation Disorder

Intervention

Drug:
• Human 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.
• clomiphene citrate alone
clomiphene citrate alone without hCG trigger

Locations

Country	Name	City	State
Egypt	faculty of medicine , Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;(1):CD006900. doi: 10.1002/14651858.CD006900.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	chemical pregnancy	A positive urine pregnancy test done 7 days after missing the period	1 year
Secondary	Clinical pregnancy	demonstration of a fetal heart beat on transvaginal ultrasound between 6 and 7 weeks of gestation.	1 year