Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

NCT ID: NCT02492451

Last Updated: 2016-10-20

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus.

Group 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Goup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention.

The effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Endometrial Injury

Endometrial injury in luteal phase of preceding IUI cycle

Group Type ACTIVE_COMPARATOR

Endometrial Injury

Intervention Type OTHER

Endometrial injury in luteal phase of preceding cycle by pipelle canula

Luteal Phase Support

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.

Group Type ACTIVE_COMPARATOR

progesterone (Crinone® %8 vaginal progesterone gel)

Intervention Type 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.

Control group

Only IUI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endometrial Injury

Endometrial injury in luteal phase of preceding cycle by pipelle canula

Intervention Type OTHER

progesterone (Crinone® %8 vaginal progesterone gel)

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Selcuk Selcuk

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk Selcuk

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 36278845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33734431 (View on PubMed)

Other Identifiers

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zeynepkamil

Identifier Type: -

Identifier Source: org_study_id

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