Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

Pregnancy Clinical Trial

Official title:

Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02492451
• Other study ID #: zeynepkamil
• Status: Recruiting
• Phase: Phase 1
• First received: June 18, 2015
• Last updated: July 9, 2015
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2015
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: Selcuk Selcuk, MD
• Phone: +905321630488
• Email: md_sel[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Endometrial Injury
Endometrial injury in luteal phase of preceding cycle by pipelle canula

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Selcuk Selcuk	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate		12 weeks	Yes