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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02186782
Date of registration:	28/06/2014
Prospective Registration:	No
Primary sponsor:	Maher elesawi kamel elesawi
Public title:	Concomitant CC and E2 Versus CC Alone in Ovulation Induction
Scientific title:	Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial
Date of first enrolment:	June 2014
Target sample size:	600
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02186782
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
Egypt

Contacts

Name:	Mohamed S Abdelhafez, Dr
Address:
Telephone:
Email:
Affiliation:	Mansoura University

Name:	Maher E Kamel Elesawi, Dr
Address:
Telephone:	+201016103662
Email:	maherelesawi@yahoo.com
Affiliation:

Name:	Ahmed M Badawy, Prof
Address:
Telephone:
Email:
Affiliation:	Mansoura University

Name:	Maher E Kamel Elesawi, Dr
Address:
Telephone:
Email:
Affiliation:	Mansoura University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Infertile women with eugonadotrophic anovulation/oligoovulation.

- Unexplained infertility.

Exclusion Criteria:

- Age < 20 or > 35 years.

- Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.

- Presence of any infertility factor other than anovulation/oligoovulation.

- Previous history of ovarian surgery or surgical removal of one ovary.

- Previous exposure to cytotoxic drugs or pelvic irradiation.

- Metabolic or hormonal abnormalities.

Age minimum: 20 Years
Age maximum: 39 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Anovulation

Intervention(s)

Drug: Clomiphene citrate and Estradiol

Drug: Clomiphene citrate and Placebo

Primary Outcome(s)

Clinical pregnancy rate [Time Frame: 6-8 weeks gestational age]

Secondary Outcome(s)

Endometrial thickness on day of HCG administration [Time Frame: 3 months]

Secondary ID(s)

ME1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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