NCT04210765

Brief Summary

This study was planned to assess the initial and endogenous FSH, LH and steroid responses to incremental CC doses in successive ovulation induction cycles to treat anovulation in patients with unexplained infertility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_4

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

August 2, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2020

Completed
Last Updated

February 3, 2021

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

December 13, 2019

Last Update Submit

February 2, 2021

Conditions

Unexplained InfertilityOvulation Disorder

Keywords

infertilityunexplained infertilityovulation inductionclomiphene citrate

Outcome Measures

Primary Outcomes (2)

  • Changes in the endogenous blood levels of FSH, LH in successive cycles

    FSH (mIU/ml), LH (mIU/ml) blood levels measured with Enzyme-Linked ImmunoSorbent Assay (ELISA) tests.

    Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days

  • Changes in the endogenous blood levels of steroids (including Androstenedione, Progesterone, Testosterone, estradiol) in successive cycles

    Blood levels of steroids: Androstenedione (ng/ml), Progesterone (ng/ml), Testosterone (ng/ml), estradiol (pg/ml) measured with ELISA tests.

    Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days)

Secondary Outcomes (1)

  • conception rate

    15-20 days following intrauterine insemination.

Study Arms (2)

Clomiphene citrate group 1

ACTIVE COMPARATOR

Clomiphene citrate dose 50mg/day for 5 days starting on cycle day (2-4).

Drug: Clomiphene Citrate

Clomiphene citrate group 2

ACTIVE COMPARATOR

Non-responsive to ovulation induction with Clomiphene Citrate with dose:50mg/day; and treated with dose:100mg/day in the succeeding cycle for 5 days, starting on cycle day (2-4).

Drug: Clomiphene Citrate

Interventions

Clomiphene CitrateDRUG

Clomiphene citrate used in incremental doses in nonresponsive cases.

Also known as: CC
Clomiphene citrate group 1Clomiphene citrate group 2

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with unexplained infertility
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • unexplained infertility
  • first-line treatment
  • Normal or increased ovarian reserve
  • lack of ovulatory response to CC 50mg for 5 days

You may not qualify if:

  • Male factor
  • Tubal Factor
  • Severe endometriosis
  • Previous ovarian surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Teaching and Research Hospital

Istanbul, Bagcilar, 34200, Turkey (Türkiye)

Location

Related Publications (2)

  • Ozyurek ES, Yoldemir T, Artar G. Androstenedione response to recombinant human FSH is the most valid predictor of the number of selected follicles in polycystic ovarian syndrome: (a case-control study). J Ovarian Res. 2017 May 12;10(1):34. doi: 10.1186/s13048-017-0330-7.

    PMID: 28494798BACKGROUND

  • Hager M, Horath S, Frigo P, Koch M, Marculescu R, Ott J. Changes in serum markers of patients with PCOS during consecutive clomiphene stimulation cycles: a retrospective study. J Ovarian Res. 2019 Oct 4;12(1):91. doi: 10.1186/s13048-019-0564-7.

    PMID: 31585548BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Evrim E Kovalak, MD

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 26, 2019

Study Start

August 2, 2019

Primary Completion

May 20, 2020

Study Completion

May 25, 2020

Last Updated

February 3, 2021

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)