NCT03316469

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

October 10, 2017

Last Update Submit

June 26, 2018

Conditions

Polycystic Ovary Syndrome

Keywords

Anti-mullerian hormone

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days

Study Arms (2)

Group A: CC & ovulation

EXPERIMENTAL

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 CitrateDiagnostic Test: Follicular growth

Group B: CC & no ovulation

EXPERIMENTAL

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 CitrateDiagnostic Test: Follicular growth

Interventions

Clomiphene CitrateDRUG

100 mg daily will be provided to the subjects to be taken for 5 days starting from day 2 of their spontaneous periods

Also known as: Clomide
Group A: CC & ovulationGroup B: CC & no ovulation
Follicular growthDIAGNOSTIC_TEST

Follicular growth assessment by TVU will be performed at day 12 of the menstrual period.

Group A: CC & ovulationGroup B: CC & no ovulation

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 16418211BACKGROUND

  • 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.

    PMID: 17698904BACKGROUND

  • 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.

    PMID: 18675414BACKGROUND

  • 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.

    PMID: 14585887BACKGROUND

  • 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.

    PMID: 16766228BACKGROUND

  • 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.

    PMID: 17156783BACKGROUND

  • 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.

    PMID: 9661609BACKGROUND

  • 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.

    PMID: 16337728BACKGROUND

  • 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.

    PMID: 14715867BACKGROUND

  • 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.

    PMID: 19261276BACKGROUND

  • Messinis IE. Ovulation induction: a mini review. Hum Reprod. 2005 Oct;20(10):2688-97. doi: 10.1093/humrep/dei128. Epub 2005 Jul 8.

    PMID: 16006478BACKGROUND

  • Hintze, J. (2011). PASS 11. NCSS, LLC. Kaysville, Utah, USA.

    BACKGROUND

  • Balen A. Ovulation induction. Obstet Gynaecol Reprod Med. 2004;14:261-268.

    BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of obs & gyn.

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 20, 2017

Study Start

July 1, 2018

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06