Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

Not Applicable

Terminated

• Conditions: Pregnancy
• Interventions: Drug: progesterone (Crinone® %8 vaginal progesterone gel); Other: Endometrial Injury

• Registration Number: NCT02492451
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-07-15
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-26
• Last Update Submitted: 2016-08-26
• Results First Posted: 2016-10-20
• Last Update Posted: 2016-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 118

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Luteal Phase Support	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.
Endometrial Injury	Endometrial Injury	Endometrial injury in luteal phase of preceding IUI cycle

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate	12 weeks	ongoing pregnancy rates

Trial Locations

Locations (1)

Selcuk Selcuk; 🇹🇷 İstanbul, Turkey