A RCT on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing FET Cycles

NCT02197832 | Terminated

• 1 other identifier: HKU-VL-FETEA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised controlled trial on the effect of endometrial injury in the cycle preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that endometrial injury will increase the ongoing pregnancy rate in FET cycles.

Conditions

Subfertility

Keywords

Frozen thawed embryo transfer; Endometrial injury; Ongoing pregnancy rates

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Pregnancy at 10-12 weeks

  pregnancy at 10-12 weeks

Secondary Outcomes (2)

• Implantation rate

  4-6 weeks after embryo transfer

• Clinical pregnancy rate

  6 weeks after embryo transfer

Study Arms (2)

EA

EXPERIMENTAL

in the cycle immediately preceding the scheduled FET treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and they will be instructed to use non-hormonal means of contraception during that cycle.

Procedure: Endometrial biopsy

Control

PLACEBO COMPARATOR

The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix but not into the uterine cavity, only entering the endocervical canal as control.

Procedure: control procedure; Device: Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France)

Interventions

Endometrial biopsy PROCEDURE

The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix up to the uterine fundus. The piston was drawn back to the end of the sheath to create a negative pressure. The sheath was rotated and moved back and forth between the fundus and internal os for at least 3-4 times before it was gently withdrawn.

EA

control procedure PROCEDURE

Using pipelle catheter without entering the uterine cavity.

Control

Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France) DEVICE

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing FET treatment cycles
• Normal uterine cavity as shown on transvaginal scanning or saline sonogram done at baseline
• endometrial thickness \>=8mm during the stimulated IVF cycle and FET cycle

You may not qualify if:

• Pregnancy in previous IVF or FET cycles
• Presence of hydrosalpinx not surgically corrected prior to FET
• Presence of endometrial polyp or fibroid distorting uterine cavity
• IVF cycles carried out for preimplantation genetic diagnosis
• Arrange for blastocyst transfer
• Use of donor oocytes

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, 852, Hong Kong

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Vivian CY Lee, MBBS

  Queen Mary Hospital / University of Hong Kong.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 23, 2014
• Study Start: September 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

HK (1)