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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03316469
• Other study ID #: Narges Essam protocol 2017
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: December 2018

Study information

• Verified date: June 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & 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. Epub 2006 Jan 17. — View Citation

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

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. Epub 2007 Aug 14. — View Citation

Dumesic DA, Lesnick TG, Stassart JP, Ball GD, Wong A, Abbott DH. Intrafollicular antimüllerian 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. — View 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. — View 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. Epub 2006 Dec 6. — View Citation

Hart R, Norman R. Polycystic ovarian syndrome--prognosis and outcomes. Best Pract Res Clin Obstet Gynaecol. 2006 Oct;20(5):751-78. Epub 2006 Jun 12. Review. — View Citation

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

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. — View 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. Epub 2005 Dec 7. — View Citation

Laven JS, Mulders AG, Visser JA, Themmen AP, De Jong FH, Fauser BC. Anti-Müllerian hormone serum concentrations in normoovulatory and anovulatory women of reproductive age. J Clin Endocrinol Metab. 2004 Jan;89(1):318-23. — View 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. — View Citation

Messinis IE. Ovulation induction: a mini review. Hum Reprod. 2005 Oct;20(10):2688-97. Epub 2005 Jul 8. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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