Condition category
Urological and Genital Diseases
Date applied
20/09/2015
Date assigned
26/11/2015
Last edited
26/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In order for a woman to become pregnant, the fertilised egg must attach (implant) itself to the lining of the womb (endometrium). In order for this to be successful, the implantation must happen within a small window of opportunity, known as the “implantation window”. It is only within the implantation window that the endometrium is receptive, and the fertilised egg (embryo) can attach to it. In vitro fertilisation (IVF) is a technique used to help people with fertility problems to have a baby. During IVF, the egg is fertilised by the sperm outside of the body to create an embryo and then returned to the woman’s uterus to develop. Although IVF has become more and more successful in recent years, there is still a relatively high failure rate. In many cases, some of the embryos are frozen so that they can be used in the next cycle of IVF (frozen embryo transfer). A possible reason for this is that the implantation window is being missed, and so the embryos are not able to attach. Pinopodes, are large rounded nodules found on the endometrium. It is thought that pinopode production is related to the hormone progesterone. Studies have shown that the presence of lots of pinopodes is linked to successful implantation. The aim of this study is to find out the whether detecting pinopodes can help to predict the window of implantation of endometrium, increasing the number of implantations.

Who can participate?
Women aged below 35 years, in their first round of IVF treatment.

What does the study involve?
All participants receive hormone replacement therapy (injection of natural female hormones) from day 3 of their menstrual cycle. They receive injections of 3mg Oestradiol valerate (a female oestrogen hormone) for 7 days, increasing toe 4mg twice a day for the next 6 days. The endometrium (lining of the womb) is now a 8mm in thickness, and a sample is taken so that it can be looked at under a microscope to look for pinopodes. The amount of pinopodes found are then used to predict the likelihood of the woman becoming pregnant in her next cycle, when she undergoes IVF. In the next cycle, the woman receives the same hormone replacement therapy as well as having a thawed embryo (frozen from a previous cycle) transferred into her womb. The amount of women who successfully become pregnant is then recorded and compared to the predictions from the pinopode detection.

What are the possible benefits and risks of participating?
Participants may benefit from a better chance of pregnancy, if the detection of pinopodes is accurate. There are no significant risks of participating, however participants may experience vaginal bleeding for infection after biopsy.

Where is the study run from?
Sir Run Run Shaw Hospital (China)

When is the study starting and how long is it expected to run for?
October 2015 to May 2016

Who is funding the study?
Heath and Family Planning Commission of ZheJiang Provence (China)

Who is the main contact?
Ms Lijuan Zhao

Trial website

Contact information

Type

Scientific

Primary contact

Ms Lijuan Zhao

ORCID ID

http://orcid.org/0000-0001-6802-7646

Contact details

N0.3 Road
QingChun Dong
Hangzhou
310016
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The pinopodes detection could predict the endometrial receptivity in infertile women

Acronym

Study hypothesis

Pinopodes could be considered as a potential biological marker of endometrial receptivity. Detecting the pinopodes may have great clinical value in predicting the window of implantation of endometrium.

Ethics approval

Ethic committee Sir Run Run Shaw Hospital, 30/10/2015, ref: 20151105-9

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Infertility

Intervention

Frozen-thawed embryo transfer (FET) is a safe and cost-effective adjunct to In Vitro Fertilization (IVF) treatment. Endometrial preparation protocols for FET commonly include natural and hormone replacement treatment (HRT). In the study, all patients undergo a modeling HRT cycle. That is, from day 3 of the menstrual cycle with Oestradiol valerate (Progynova; Schering AG, Berlin, Germany) 3 mg two times a day for 7 days, increasing to 4 mg two times a day for the next 6 days. When the endometrium reached a thickness of 8mm, then progesterone were consecutively injected IM 80mg for 6 days in all patients. Endometrial biopsies are taken on the day after the last progesterone injection, for pinopode detection by Scanning Electron Microscopy (SEM). The results from the pinopode detection will be used to predict the outcome of the next HRT-FET cycle the patients undergo. In the next cycle, all patients will undergo conventional HRT-FET regimes. All subjects were followed up whether clinical pregnancy in 5 weeks -7 weeks after FET operation.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

Embryo implantation rate is determined by measuring the number of gestational sacs present on ultrasound divided by the number of embryos transferred 5-7 weeks after embryo transfer.

Secondary outcome measures

Clinical pregnancy rate is determined by testing serum hCG levels and transvaginal ultrasound scanning 5-7 weeks after embryo transfer.

Overall trial start date

01/10/2015

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female participants only
2. Aged below 35 years
3. Tube factors or male factor infertility
4. First IVF treatment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

92 cases

Participant exclusion criteria

1. Uterine organic diseases such as uterine fibroids or denomyosis
2. Internal and external genital malformation and hydrosalpinx

Recruitment start date

30/10/2015

Recruitment end date

01/05/2016

Locations

Countries of recruitment

China

Trial participating centre

Sir Run Run Shaw Hospital
Assisted Reproduction center Department of Obstetrics and Gynecology Zhejiang University School of Medicine 3 Qingchun E Rd
Hangzhou
310016
China

Sponsor information

Organisation

Heath and Family Planning Commission of ZheJiang Provence

Sponsor details

No,216 Road
QingChun
Hangzhou
310002
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Heath and Family Planning Commission of ZheJiang Provence

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a reproduction related journal.

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes