Endometrial Injury Increases Implantation and Pregnancy Rates

NCT01340560 | Completed

• 1 other identifier: ref.no:2008-274
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objective To evaluate the effect of local injury to the endometrium for implantation, pregnancy and live birth rates in ICSI -ET cycles with recurrent implantation failure. Design Randomized controlled clinical study. Setting A clinical will assist reproductive center of Selcuk University Meram Medical Faculty Hospital in the Konya, Turkey. Population A group of 100 women, who failed to conceive during one or more cycles of IVF and embryo transfer (ET), will treat with a long protocol for controlled ovarian hyperstimulation. Methods The IVF treatment and ET will precede by repeated endometrial biopsies, in a randomly selected 50 of a total of 100 women.

Conditions

Focus of Study Instead

Keywords

Endometrium, local injury, implantation, pregnancy, in vitro fertilization

Outcome Measures

Primary Outcomes (3)

• Implantation ratio

  Implantation ratios were 30.88% in Group 1 and 34.67% in Group 2 (p =0.13). So there wasn't any significant difference for implantation ratios between two groups, but implantation ratio of 34.67% in Group 2 was evaluated as clinically significant

  Six months

• Clinical pregnancy ratio

  Cardiac activity on USG for clinical pregnancy were determined in seventeen women of the control group (34%) and 30 women of the study group (60%). The clinical pregnancy rate was significiantly higher in the study group with compared to control group (p=0.009)

  six months

• Live birth ratio

  Twenty two of the 30 pregnancies in the study group ended in the delivery of 27 healthy babies. This stituation represents a rate of live births in the study group that was significiantly higher than control group (44% and 24%) (p= 0.03)

  six months

Secondary Outcomes (3)

• Implantation ratio

  six months

• Clinical pregnancy ratio

  six months

• Live birth ratio

  six months

Interventions

Endometrial biopsy PROCEDURE

Endometrial biopsy was performed with biopsy catheter

Eligibility Criteria

• Age: 25 Years - 36 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women who applied to our clinic due to infertility and who undergone one or more failed fresh IVF cycles previously has been included in our study for ICSI-ET (intracytoplasmic sperm injection-embryo transfer).

You may not qualify if:

• women with factors as hydrosalpenx, trombophilia, submucous myoma and found to have a negative impact on implantation

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

IVF Unit, Department of Obstetrics and Gynecology, Selcuk University Meram Medical Faculty

Konya, 04220, Turkey (Türkiye)

Location

Related Publications (1)

• Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.

  PMID: 34110001 DERIVED

Related Links

• Selcuk University

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 22, 2011
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 22, 2011

Record last verified: 2011-04

Locations

TU (1)