ClinicalTrials.gg
Status unknownNCT03316469Updated Jun 27, 2018

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

An interventional study of Clomiphene Citrate and Follicular growth in Polycystic Ovary Syndrome, sponsored by Ain Shams University. Status unknown. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by Ain Shams University · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

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Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Anti-mullerian hormone
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In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women diagnosed with PCOS
  • Women 20-35 years old.
  • ≤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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Group A: CC & ovulation

    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 Citrate · Diagnostic Test: Follicular growth

  • Experimental
    Group B: CC & no ovulation

    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 Citrate · Diagnostic Test: Follicular growth

Interventions

  • 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

  • Diagnostic testFollicular growth

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

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What researchers measure

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.

    Time frame: 10 days

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 16418211 ↗
  • 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. PubMed 17698904 ↗
  • 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. PubMed 18675414 ↗
  • 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. PubMed 14585887 ↗
  • 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. PubMed 16766228 ↗
  • 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. PubMed 17156783 ↗
  • 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. PubMed 9661609 ↗
  • 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. PubMed 16337728 ↗
  • 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. PubMed 14715867 ↗
  • 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. PubMed 19261276 ↗
  • Messinis IE. Ovulation induction: a mini review. Hum Reprod. 2005 Oct;20(10):2688-97. doi: 10.1093/humrep/dei128. Epub 2005 Jul 8. PubMed 16006478 ↗
  • Hintze, J. (2011). PASS 11. NCSS, LLC. Kaysville, Utah, USA.
  • Balen A. Ovulation induction. Obstet Gynaecol Reprod Med. 2004;14:261-268.
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2018; primary completion for Oct 2018, 3 months later.

Of 202 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 3 months is below that.

Counting every sponsor, half of 217 studies reached it within 18 months; a quarter within 7 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2017
First posted
Oct 20, 2017
StartEst.
Jul 2018
Primary completionEst.
Oct 2018
CompletionEst.
Dec 2018
Last update
Jun 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03316469
Responsible party
Narges Essam El-din Marrey (Resident of obs & gyn., Ain Shams University) — Principal investigator
First posted
Oct 20, 2017
Start date
Jul 2018 (estimated)
Primary completion
Oct 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jun 27, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Clomiphene

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