Anti-Mullerian Hormone as Predictor of Ovarian Responce to Clomiphene Citrate in PCOS

June 26, 2018 updated by: Narges Essam El-din Marrey, Ain Shams University

Circulating Anti-mullerian Hormone as Predictor of Ovarian Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is found in 5% to 6% of women of reproductive age. It affects women's reproductive capability; thus patients have risks of infertility, miscarriage, and complicated pregnancy. A study revealed that the prevalence of oligoovulation or anovulation in patients with PCOS ranged from 65% to 80%. Anti-Mullerian Hormone (AMH) is an important regulator in the ovary that play a rule during development and function. It is suspected to affect clomiphene citrate (cc) resistance. In this study the investigator will assess the accuracy of AMH prediction of response to cc in women with PCOS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women diagnosed with PCOS
  • Women 20-35 years old.
  • BMI ≤30 kg/m without previous ovulation induction.
  • Partners with normal semen parameters Parameter World Health Organization (WHO) 2010 Volume1.5 ml Concentration 15 million/ml Progressive motility 32% Normal forms 4%

Exclusion Criteria:

  • Women with evidence of hyper-or hypothyroidism, hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia or androgen-secreting tumors.
  • Women with factors of infertility other than PCOS
  • Women with incomplete data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: CC & ovulation
AMH level is measured before Clomiphene citrate 100 mg daily for 5 days & detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.
Drug: Clomiphene Citrate
100 mg daily will be provided to the subjects to be taken for 5 days starting from day 2 of their spontaneous periods
Other Names:
  • Clomide
Diagnostic test: Follicular growth
Follicular growth assessment by TVU will be performed at day 12 of the menstrual period.
Experimental: Group B: CC & no ovulation
AMH level is measured before Clomiphene citrate 100 mg daily for 5 days & detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.
Drug: Clomiphene Citrate
100 mg daily will be provided to the subjects to be taken for 5 days starting from day 2 of their spontaneous periods
Other Names:
  • Clomide
Diagnostic test: Follicular growth
Follicular growth assessment by TVU will be performed at day 12 of the menstrual period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH in prediction of Ovulation in women with PCOS.
Time Frame: 10 days
AMH level is measured 10 days before expected date of ovulation then correlated to ovulation either successfully or not.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Narges Essam protocol 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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