ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000657628

Ethics application status

Approved

Date submitted

10/06/2014

Date registered

24/06/2014

Date last updated

10/05/2022

Date data sharing statement initially provided

26/11/2018

Date results provided

26/02/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Pipelle for pregnancy in couples with subfertility related to polycystic ovarian syndrome

Scientific title

A single-blind, randomised controlled trial assessing the effect of endometrial pipelle biopsy vs. sham biopsy on live birth rate in couples with subfertility related to polycystic ovarian syndrome

Secondary ID [1]

nil

Universal Trial Number (UTN)

U111111556458

Trial acronym

PIP-PCOS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Polycystic ovarian syndrome

Condition category

Condition code

Reproductive Health and Childbirth

Fertility including in vitro fertilisation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Women will undergo a single endometrial pipelle biopsy performed between days 1 and 12 of a stimulated cycle (clomiphene, letrozole or metformin).

Intervention code [1]

Treatment: Other

Comparator / control treatment

Women will undergo a single endometrial sham biopsy (the biopsy cannula will be placed at the anterior fornix and not inserted into the uterus). This procedure will be performed between days 1 and 12 of a stimulated cycle (clomiphene, letrozole or metformin).

Control group

Placebo

Outcomes

Primary outcome [1]

Live birth - delivery of a live infant at least 20 weeks gestation

Timepoint [1]

Approximately 9 months following the end of the study period

Secondary outcome [1]

Clinical pregnancy - on ultrasound, the presence of at least one gestational sac

Timepoint [1]

6 weeks following each ovulation induction cycle (3 consecutive ovulation induction cycles, unless pregnancy occurs)

Secondary outcome [2]

Ongoing pregnancy - on ultrasound, the presence of at least one gestational sac and heartbeat

Timepoint [2]

12 weeks following each ovulation induction cycle (3 consecutive ovulation induction cycles, unless pregnancy occurs)

Secondary outcome [3]

Multiple pregnancy - on ultrasound, the presence of more than one heartbeat

Timepoint [3]

6 weeks following each ovulation induction cycle (3 consecutive ovulation induction cycles, unless pregnancy occurs)

Secondary outcome [4]

Adverse events - including miscarriage, ectopic pregnancy, pain or bleeding following the procedure, infection etc.

Timepoint [4]

Bleeding and pain: on the day of the procedure or the following day
Infection: for 1 month following the procedure
Ectopic pregnancy and miscarriage: up to 20 weeks following the cycle in which pregnancy occurs

Eligibility

Key inclusion criteria

1. Couples having regular unprotected sexual intercourse in a relationship where pregnancy is desired
2. Women is between 18-42 years of age at the time of randomisation
3. Women who meet the criteria for PCOS, at least two of the following: 1) oligoovulation or anovulation (progesterone test) 2) excess androgen activity (elevated serum testosterone or clinical signs such as excess hair), 3) polycystic ovaries (as evidenced on ultrasound) – as per the Rotterdam criteria
4. Have either a) two ovaries and two probably patent fallopian tube (confirmed by hysteroscopy or HSG - one tube may spasm/not free spill). b) been ovulating on ovulation induction mediction for 6 months or less (as HSG may not be recommended until failure to achieve pregnancy following three or more cycles of successful ovulation), or c) A previous intrauterine pregnancy, and no subsequent surgery or ectopic pregnancy that may reduce tubal patency or ovarian function
5. A body mass index (BMI) less than or equal to 35
6. Have a negative cervical PAP smear within the last 3 years
7. Be willing to have regular sexual intercourse following the procedure in the month of the procedure, and for two months following the procedure (or until pregnancy occurs). For PCOS women, this includes three months of consecutive ovulation induction (unless pregnancy occurs)
8. Be willing to remain on ovulation induction medication for the study period (unless pregnancy occurs), either: clomiphene, letrozole or metformin (or a combination). Doses may vary.
9. Women who’s male partner has normal semen analysis (volume at least 1.5ml, progressive motility at least 32%, concentration at least 15million/ml) or a total motile count of equal to or more than 10 million

Minimum age

18 Years

Maximum age

42 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

1. Have had any disruptive instrumentation within the uterine cavity (e.g. hysteroscopy, hysterosalpingogram, laparoscopy, surgically managed miscarriage or endometrial biopsy) within three months prior to day one of the planned ovulation induction cycle, or planning to undergo a procedure involving disruptive instrumentation at any stage during the study.
2. The presence of any other cause of infertility, where spontaneous conception is unlikely (e.g. large fibroids)
3. Recurrent miscarriage
4. Entered previously into this study or participation in another trial in the last 30 days
5. Any contraindication to endometrial biopsy or being pregnant and/or carrying a pregnancy to term

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

To ensure allocation concealment, randomisation of eligible individuals will be performed by an online randomisation system built into the data collection software.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer generated block randomisation schedule, stratified for each fertility centre, will be created and protected by the database manager

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2014

Actual

27/06/2014

Date of last participant enrolment

Anticipated

Actual

31/12/2019

Date of last data collection

Anticipated

Actual

31/12/2020

Sample size

Target

280

Accrual to date

Final

117

Recruitment outside Australia

Country [1]

Brazil

State/province [1]

Country [2]

Egypt

State/province [2]

Cairo

Country [3]

New Zealand

State/province [3]

Country [4]

United Kingdom

State/province [4]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Auckland District Health Board

Address [1]

Bldg 14, Greenlane Clinical Centre Level 7/214 Green Ln W, Greenlane 1051

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Auckland District Health Board

Address

Bldg 14, Greenlane Clinical Centre Level 7/214 Green Ln W, Greenlane 1051

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

29/04/2014

Approval date [1]

06/06/2014

Ethics approval number [1]

14/NTA/62

Summary

Brief summary

The favourable effect of local endometrial biopsy (LEB) in women undergoing embryo transfer or natural conception indicates that the LEB somehow enhances the endometrial receptivity in a group of women whose endometrium is otherwise not adequately receptive to an implanting embryo. As it is likely that poor endometrial receptivity is at least partly contributing to the experienced infertility in cases of polycystic ovarian syndrome (PCOS), LEB may also be beneficial for these couples. 
Unfortunately, research concerning the utility of LEB in couples with subfertility related to PCOS is sparse. 
We plan to address the current limitations by conducting a pragmatic, double-blind, randomised controlled trial of LEB in couples with subfertility related to PCOS.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Cynthia Farquhar

Address

Department of Obstetrics and Gynaecology and National Women's Health, University of Auckland, Level 12, ACH Support Building, Auckland City Hospital, Park Road, Grafton Private Bag 92019 Auckland 1020

Country

New Zealand

Phone

+64 9 3737599 EXT 89493

Fax

c.farquhar@auckland.ac.nz

Contact person for public queries

Name

Sarah Lensen

Address

Country

New Zealand

Phone

+64 9 3737599 EXT 89487

Fax

s.lensen@auckland.ac.nz

Contact person for scientific queries

Name

Cynthia Farquhar

Address

Country

New Zealand

Phone

+64 9 3737599 EXT 89493

Fax

c.farquhar@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All IPD, anonymised

When will data be available (start and end dates)?

After data analysis for the primary study; approx mid 2021. IPD will be available for at least 5 years after this date, no end date determined

Available to whom?

Researchers with bonafide research questions, e.g. IPD projects

Available for what types of analyses?

Variable

How or where can data be obtained?

By sending an email request to c.farquhar@auckland.ac.nz

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10820	Study protocol	DOI 10.1186/s13063-016-1301-9	https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-016-1301-9	c.farquhar@auckland.ac.nz	Na	366423-(Uploaded-27-07-2020-09-02-26)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A randomized trial of endometrial scratching in women with PCOS undergoing ovulation induction cycles.	2022	https://dx.doi.org/10.1016/j.rbmo.2021.10.008

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically