NCT02345837

Brief Summary

The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

January 20, 2015

Last Update Submit

April 4, 2016

Conditions

Asymptomatic Diseases

Outcome Measures

Primary Outcomes (3)

  • Clinical pregnancy rate.

    one year

  • Miscarriage rate.

    one year

  • Multiple pregnancy rates

    one year

Study Arms (2)

clomiphene and endometrial sampling

ACTIVE COMPARATOR

Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.

Device: endometrial samplingDrug: clomiphene citrate

clomiphene citrate

ACTIVE COMPARATOR

Couples who will undergo ovulation induction with clomiphene citrate.

Drug: clomiphene citrate

Interventions

endometrial samplingDEVICE

injury to the endometrium

clomiphene and endometrial sampling
clomiphene citrateDRUG

ovulation induction by 100mg clomiphene citrate

Also known as: clomid
clomiphene and endometrial samplingclomiphene citrate

Eligibility Criteria

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

You may qualify if:

  • Male partner should have a normal semen count and motility according to world health organization criteria (Murray et al., 2012).
  • Primary, secondary or unexplained infertility for at least one year.
  • Failure to conceive with clomiphene citrate in spite of good follicular response for at least 3 cycles.
  • Age varies from 20-35 years with at least one year of infertility.
  • Body mass index between 19-30 kg/m2.
  • Day 2 serum FSH\< 12 IU/ml.
  • Normal uterine cavity on hystrosalpingography.
  • At least one patent tube of normal appearance on HSG.
  • No previous attempts of intrauterine insemination (IUI) or in vitro fertilization (IVF).

You may not qualify if:

  • Infertility due to tubal factor or male factor.
  • Intrauterine organic pathology (myoma, polyp, adhesions) by hystrosalpingogram or diagnostic hysteroscope.
  • Hypogonadotrophic hypogonadism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Shebin Elkom, Egypt

RECRUITING

Related Publications (1)

  • Helmy MEE, Maher MA, Elkhouly NI, Ramzy M. A randomized trial of local endometrial injury during ovulation induction cycles. Int J Gynaecol Obstet. 2017 Jul;138(1):47-52. doi: 10.1002/ijgo.12178. Epub 2017 May 4.

    PMID: 28397981DERIVED

MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • menoufia university

    menoufia fuculty of medicine

    STUDY CHAIR

Central Study Contacts

mohamed maher

CONTACT

+966558198655mohamaher2015@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

February 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

EG(1)