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Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

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ClinicalTrials.gov Identifier: NCT02492451
Recruitment Status : Terminated (Problems in recruitment)
First Posted : July 8, 2015
Results First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Selcuk Selcuk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Endometrial Injury Drug: progesterone (Crinone® %8 vaginal progesterone gel) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Endometrial Injury
Endometrial injury in luteal phase of preceding IUI cycle
 Other: Endometrial Injury
Endometrial injury in luteal phase of preceding cycle by pipelle canula
Active Comparator: 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.
 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.
No Intervention: Control group
Only IUI


Outcome Measures
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Primary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 12 weeks ]
    ongoing pregnancy rates


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492451


Locations
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Turkey
Selcuk Selcuk
İstanbul, Turkey
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Selcuk Selcuk, Medical Doctor, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier: NCT02492451    
Other Study ID Numbers: zeynepkamil
First Posted: July 8, 2015    Key Record Dates
Results First Posted: October 20, 2016
Last Update Posted: October 20, 2016
Last Verified: August 2016
Keywords provided by Selcuk Selcuk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital:
intrauterine insemination
pregnancy rate
endometrial injury
Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs