NCT02492451

Brief Summary

The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
118

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 20, 2016

Completed
Last Updated

October 20, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

June 18, 2015

Results QC Date

July 15, 2016

Last Update Submit

August 26, 2016

Conditions

Pregnancy

Keywords

intrauterine inseminationpregnancy rateendometrial injury

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Rate

    ongoing pregnancy rates

    12 weeks

Study Arms (3)

Endometrial Injury

ACTIVE COMPARATOR

Endometrial injury in luteal phase of preceding IUI cycle

Other: Endometrial Injury

Luteal Phase Support

ACTIVE COMPARATOR

Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Drug: progesterone (Crinone® %8 vaginal progesterone gel)

Control group

NO INTERVENTION

Only IUI

Interventions

Endometrial InjuryOTHER

Endometrial injury in luteal phase of preceding cycle by pipelle canula

Endometrial Injury
progesterone (Crinone® %8 vaginal progesterone gel)DRUG

Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Luteal Phase Support

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients are undergone intrauterine insemination with gonadotropin stimulation
  • Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy
  • After semen preparation for intrauterine insemination, total progressive sperm count \> 5 million

You may not qualify if:

  • endocrin or metabolic disorders,
  • uterine factor,
  • pelvic inflammatory disease,
  • women with basal follicle-stimulating hormone (FSH) level \>15 IU/mL,
  • body mass index (BMI) ≥ 35 kg/m2,
  • age ≥ 40 and \< 18 years,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk Selcuk

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Bui BN, Lensen SF, Gibreel A, Martins WP, Torrance H, Broekmans FJ. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2022 Oct 24;10(10):CD011424. doi: 10.1002/14651858.CD011424.pub4.

    PMID: 36278845DERIVED

  • Bui BN, Lensen SF, Gibreel A, Martins WP, Torrance H, Broekmans FJ. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2021 Mar 18;3(3):CD011424. doi: 10.1002/14651858.CD011424.pub3.

    PMID: 33734431DERIVED

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Results Point of Contact

Title
Selcuk Selcuk
Organization
Zeynep Kamil Research and Teaching Hospital
md_sel@hotmail.com
+905321630488

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 18, 2015

First Posted

July 8, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 20, 2016

Results First Posted

October 20, 2016

Record last verified: 2016-08

Locations

TU(1)