NCT02548039

Brief Summary

The purpose of this study is to match the genetic component and clinical attributes of anovulatory patients with response to clomiphene treatment. By improving our understanding on patient-specific clomiphene response will allow optimization of treatment, reduction of side-effects and shorten the time-to-pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

June 1, 2018

Enrollment Period

2.2 years

First QC Date

September 8, 2015

Last Update Submit

August 5, 2018

Conditions

Infertility, Female

Keywords

AnovulatoryClomiphene

Outcome Measures

Primary Outcomes (1)

  • Achievement of successful ovulation

    Successful ovulation is defined as a mid-luteal phase serum progesterone level of \>20 nmol/L.

    Day 20-23 of menses cycle

Study Arms (1)

Asian Normogonadotrophic Anovulatory Women

Asian women with normal gonadotropin levels but do not ovulate.

Eligibility Criteria

Age21 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Asian Normogonadotrophic Anovulatory Women

You may qualify if:

  • Women of reproductive age with ovulatory dysfunction desiring pregnancy,
  • Willing to discontinue any form of herbal or traditional chinese medicines for at least three weeks before starting Clomiphene
  • Ability to provide written and informed consent taken from participating patients, and
  • Willingness to cooperate with study instructions

You may not qualify if:

  • Pregnant at the time of recruitment,
  • Ovarian cysts more than 5cm,
  • Abnormal menorrhagia at the time of study recruitment,
  • Abnormal liver function or active liver disease,
  • Presence of neoplastic lesions of any type,
  • Primary pituitary or ovarian failure (Type I and III World Health Organisation \[WHO\] Infertility)
  • Patients with previous treatment with ovulation inducing agents such as follicle stimulating hormone (FSH) and luteinising hormone releasing hormone-analogues (LHRH-analogues);
  • Infertility due to other endocrine abnormalities such as hyperprolactinaemia, hypo/hyperthyroidism, premature ovarian failure, diabetes or male factor
  • Allergy to clomiphene.
  • Fallopian tubal pathology (hydrosalpinges, previous salpingectomies)
  • Patients on any drugs with potential to interact with CYP2D6 such as the selective serotonin receptor uptake inhibitors (ex. Venlafaxine, paroxitene, fluoxetine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (3)

  • Ghobadi C, Gregory A, Crewe HK, Rostami-Hodjegan A, Lennard MS. CYP2D6 is primarily responsible for the metabolism of clomiphene. Drug Metab Pharmacokinet. 2008;23(2):101-5. doi: 10.2133/dmpk.23.101.

    PMID: 18445989BACKGROUND

  • Rostami-Hodjegan A, Lennard MS, Tucker GT, Ledger WL. Monitoring plasma concentrations to individualize treatment with clomiphene citrate. Fertil Steril. 2004 May;81(5):1187-93. doi: 10.1016/j.fertnstert.2003.07.044.

    PMID: 15136073BACKGROUND

  • Murdter TE, Kerb R, Turpeinen M, Schroth W, Ganchev B, Bohmer GM, Igel S, Schaeffeler E, Zanger U, Brauch H, Schwab M. Genetic polymorphism of cytochrome P450 2D6 determines oestrogen receptor activity of the major infertility drug clomiphene via its active metabolites. Hum Mol Genet. 2012 Mar 1;21(5):1145-54. doi: 10.1093/hmg/ddr543. Epub 2011 Nov 22.

    PMID: 22108178BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and Genomic DNA.

MeSH Terms

Conditions

Infertility, FemaleAnovulation

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Jerry Chan, MB BCh BaO (Hons) MA,FRCOG,PhD

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 14, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2017

Study Completion

May 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-06

Locations

SG(1)