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

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ClinicalTrials.gov Identifier: NCT02673632
Recruitment Status : Unknown
Verified February 2016 by Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital

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

Condition or disease Intervention/treatment
Infertility Drug: Merional ®

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Anti-Müllerian Hormone on Ovarian Responsiveness to Ovulation Induction With Gonadotrophins in Women With Polycystic Ovarian Syndrome
Study Start Date : February 2016
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: 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.
    Other Name: Decapeptyl ®


Primary Outcome Measures :
  1. Good response to hMG therapy defined as occurrence of > 3 mature follicles after treatment. [ Time Frame: 30 days ]
    Good response to hMG therapy defined as occurrence of > 3 mature follicles after treatment.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population comprises women with PCOS, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, assisted reproductive technology (ART) Unit, during the study period, who are planning for Intracytoplasmic sperm injection (ICSI).
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673632


Contacts
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Contact: Karim L Emam, MBBCH +201001001696 kl_emam@hotmail.com
Contact: Ahmed M Bahaa eldin, A.Professor +20 1111700556 abahaa0503@med.asu.edu.eg

Sponsors and Collaborators
Ain Shams Maternity Hospital
Publications:
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Responsible Party: Ahmed Mohamed Bahaa Eldin Ahmed, Assistant professor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02673632    
Other Study ID Numbers: ASU2016
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital:
Anti-Müllerian hormone
Ovarian stimulation
Polycystic ovary syndrome
Intracytoplasmic sperm injection
Additional relevant MeSH terms:
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Infertility
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents