The Influence of AMH on Ovarian Responsiveness to Ovulation Induction With GnRH in Women With PCOS

NCT ID: NCT02673632

Last Updated: 2016-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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The investigator suggests that PCOS women with high AMH levels are resistant to ovarian stimulation and may need adjustment of the dose of gonadotrophin.

Detailed Description

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There is a correlation between high levels of AMH and the severity of PCOS. Excessive AMH may have a negative effect on the sensitivity of the resting follicles to gonadotropins.

This is an observational prospective study to investigate the impact of circulating AMH on gonadotrophin induction in women with PCOS.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Merional ®

Using the long protocol of controlled ovarian hyperstimulation (COH). Down regulation by (Decapeptyl ®, Ferring) 0.1mg subcutaneously once daily starting from day 18 of the preceding cycle, human menopausal gonadotrophin (hMG) (Merional ®, IBSA) 75 IU starting from cycle day two after confirmation of down regulation (thin endometrium, number of follicular activity, E2 \< 50 pg/mL). hMG dose is optimized according to age, BMI, antral follicles count (AFC), the local protocol, FSH level and previous response. Usually PCO patients start by 150 IU.

Intervention Type DRUG

Other Intervention Names

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Decapeptyl ®

Eligibility Criteria

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Inclusion Criteria

* Women of age 18 - 35 years
* BMI 20 - 30 kg/m2
* Anovulatory infertility
* Diagnosis of PCOS based on Rotterdam consensus criteria (two of three criteria: Oligo/anovulation, hyperandrogenaemia and sonographic appearance of polycystic ovaries)

Exclusion Criteria

* Women Above 35 years or under 18 years
* Women with BMI above 30 kg/m2 or under 20 kg/m2
* Normally ovulating women
* Patients with marked hyperandrogenaemia were screened for congenital adrenal hyperplasia (by measuring serum concentration of 17alpha hydroxyl-progesterone) or Patients with Cushing syndrome (by measuring urinary free cortisol)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Bahaa Eldin Ahmed

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Karim L Emam, MBBCH

Role: CONTACT

+201001001696

Ahmed M Bahaa eldin, A.Professor

Role: CONTACT

+20 1111700556

References

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Amer SA, Mahran A, Abdelmaged A, El-Adawy AR, Eissa MK, Shaw RW. The influence of circulating anti-Mullerian hormone on ovarian responsiveness to ovulation induction with gonadotrophins in women with polycystic ovarian syndrome: a pilot study. Reprod Biol Endocrinol. 2013 Dec 17;11:115. doi: 10.1186/1477-7827-11-115.

Reference Type BACKGROUND
PMID: 24341292 (View on PubMed)

Other Identifiers

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ASU2016

Identifier Type: -

Identifier Source: org_study_id

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