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

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clomiphene Citrate
Follicular growth
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Polycystic Ovary Syndrome focused on measuring Anti-mullerian hormone

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A: CC & ovulation

    Group B: CC & no ovulation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2017
    Last Updated
    June 26, 2018
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03316469
    Brief Title
    Anti-Mullerian Hormone as Predictor of Ovarian Responce to Clomiphene Citrate in PCOS
    Official Title
    Circulating Anti-mullerian Hormone as Predictor of Ovarian Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    October 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    Anti-mullerian hormone

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: CC & ovulation
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group B: CC & no ovulation
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Clomiphene Citrate
    Other Intervention Name(s)
    Clomide
    Intervention Description
    100 mg daily will be provided to the subjects to be taken for 5 days starting from day 2 of their spontaneous periods
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Follicular growth
    Intervention Description
    Follicular growth assessment by TVU will be performed at day 12 of the menstrual period.
    Primary Outcome Measure Information:
    Title
    AMH in prediction of Ovulation in women with PCOS.
    Description
    AMH level is measured 10 days before expected date of ovulation then correlated to ovulation either successfully or not.
    Time Frame
    10 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16418211
    Citation
    Azziz R. Controversy in clinical endocrinology: diagnosis of polycystic ovarian syndrome: the Rotterdam criteria are premature. J Clin Endocrinol Metab. 2006 Mar;91(3):781-5. doi: 10.1210/jc.2005-2153. Epub 2006 Jan 17.
    Results Reference
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    PubMed Identifier
    17698904
    Citation
    Catteau-Jonard S, Pigny P, Reyss AC, Decanter C, Poncelet E, Dewailly D. Changes in serum anti-mullerian hormone level during low-dose recombinant follicular-stimulating hormone therapy for anovulation in polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Nov;92(11):4138-43. doi: 10.1210/jc.2007-0868. Epub 2007 Aug 14.
    Results Reference
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    PubMed Identifier
    18675414
    Citation
    Dumesic DA, Lesnick TG, Stassart JP, Ball GD, Wong A, Abbott DH. Intrafollicular antimullerian hormone levels predict follicle responsiveness to follicle-stimulating hormone (FSH) in normoandrogenic ovulatory women undergoing gonadotropin releasing-hormone analog/recombinant human FSH therapy for in vitro fertilization and embryo transfer. Fertil Steril. 2009 Jul;92(1):217-21. doi: 10.1016/j.fertnstert.2008.04.047.
    Results Reference
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    PubMed Identifier
    14585887
    Citation
    Eijkemans MJ, Imani B, Mulders AG, Habbema JD, Fauser BC. High singleton live birth rate following classical ovulation induction in normogonadotrophic anovulatory infertility (WHO 2). Hum Reprod. 2003 Nov;18(11):2357-62. doi: 10.1093/humrep/deg459.
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    PubMed Identifier
    16766228
    Citation
    Hart R, Norman R. Polycystic ovarian syndrome--prognosis and outcomes. Best Pract Res Clin Obstet Gynaecol. 2006 Oct;20(5):751-78. doi: 10.1016/j.bpobgyn.2006.04.006. Epub 2006 Jun 12.
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    PubMed Identifier
    17156783
    Citation
    Ghobadi C, Nguyen TH, Lennard MS, Amer S, Rostami-Hodjegan A, Ledger WL. Evaluation of an existing nomogram for predicting the response to clomiphene citrate. Fertil Steril. 2007 Mar;87(3):597-602. doi: 10.1016/j.fertnstert.2006.10.002. Epub 2006 Dec 6.
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    PubMed Identifier
    9661609
    Citation
    Imani B, Eijkemans MJ, te Velde ER, Habbema JD, Fauser BC. Predictors of patients remaining anovulatory during clomiphene citrate induction of ovulation in normogonadotropic oligoamenorrheic infertility. J Clin Endocrinol Metab. 1998 Jul;83(7):2361-5. doi: 10.1210/jcem.83.7.4919.
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    PubMed Identifier
    16337728
    Citation
    Kurabayashi T, Suzuki M, Fujita K, Murakawa H, Hasegawa I, Tanaka K. Prognostic factors for ovulatory response with clomiphene citrate in polycystic ovary syndrome. Eur J Obstet Gynecol Reprod Biol. 2006 Jun 1;126(2):201-5. doi: 10.1016/j.ejogrb.2005.11.005. Epub 2005 Dec 7.
    Results Reference
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    PubMed Identifier
    14715867
    Citation
    Laven JS, Mulders AG, Visser JA, Themmen AP, De Jong FH, Fauser BC. Anti-Mullerian hormone serum concentrations in normoovulatory and anovulatory women of reproductive age. J Clin Endocrinol Metab. 2004 Jan;89(1):318-23. doi: 10.1210/jc.2003-030932.
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    Citation
    Mashiach R, Amit A, Hasson J, Amzalzg S, Almog B, Ben-Yosef D, Lessing JB, Limor R, Azem F. Follicular fluid levels of anti-Mullerian hormone as a predictor of oocyte maturation, fertilization rate, and embryonic development in patients with polycystic ovary syndrome. Fertil Steril. 2010 May 1;93(7):2299-302. doi: 10.1016/j.fertnstert.2009.01.125. Epub 2009 Mar 3.
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    PubMed Identifier
    16006478
    Citation
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    Anti-Mullerian Hormone as Predictor of Ovarian Responce to Clomiphene Citrate in PCOS

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