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

NCT ID: NCT02197832

Last Updated: 2015-12-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-03-31

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.

Detailed Description

Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong Kong who are scheduled for FET treatment will be recruited. Women who have normal uterine cavity will be randomized into study and control groups in 1 to 1 ratio according to a computer-generated randomization list.

For patients in the study group, 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. For patient in the control group, a similar procedure would be performed on the same timing during the preceding cycles without entering the uterine cavity, ie endometrial biopsy catheter entering the endocervical canal without entering the endometrial cavity. All patients will then proceed to FET treatment in the next cycle as scheduled.

The FET would be carried out as per our protocol. In short, patients attend the clinic daily from 18 days before the next expected period for the determination of serum E2 and luteinising hormone (LH) concentrations until the LH surge, which was defined as the day on which the LH level was above 20 IU/L and doubled the average of the LH levels over the past three days. For patients with irregular menstrual cycles or no ovulation demonstrated during natural cycle monitoring, clomiphene citrate (CC, Clomid, Merrell, Staines, U.K.) 50-100 mg will be given daily for five days from Days 3-7. The cycle will be monitored by blood tests from day 10 of the cycle as above. FET was performed on the third day after the LH surge. Up to two frozen-thawed embryo(s) can be transferred. No luteal phase support is used. On-going pregnancy rates, defined as viable fetuses beyond 10-12 gestational weeks, between the two groups will be compared.

We should measure endometrial thickness on LH+1 in natural and clomid-induced cycles.

Conditions

Subfertility

Keywords

Frozen thawed embryo transfer; Endometrial injury; Ongoing pregnancy rates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EA

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.

Group Type: EXPERIMENTAL

Endometrial biopsy

Intervention Type: 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.

Control

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.

Group Type: PLACEBO_COMPARATOR

control procedure

Intervention Type: PROCEDURE

Using pipelle catheter without entering the uterine cavity.

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

Intervention Type: DEVICE

Interventions

Endometrial biopsy

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.

Intervention Type: PROCEDURE

control procedure

Using pipelle catheter without entering the uterine cavity.

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivian CY Lee, MBBS

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital / University of Hong Kong.

Locations

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Countries

Hong Kong

Other Identifiers

HKU-VL-FETEA

Identifier Type: -

Identifier Source: org_study_id