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Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate

Primary Purpose

Polycystic Ovary Syndrome, Infertility

Status

Withdrawn

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Progestin

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, Progestin, Endometrial shedding, Ovulation induction cycles, Clomiphene citrate, Clinical pregnancy rate

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility
Age 18-38 years
At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
Normal semen analysis (total motile sperm count >20million/ml)
Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
Undergoing ovulation-induction with clomiphene citrate without intra-uterine insemination (IUI)

Exclusion Criteria:

Body mass index (BMI) < 17 kg/m2 or > 40 kg/m2
Prior treatment with clomiphene citrate
Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram)
Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome
Any other cause of infertility other than anovulation

Sites / Locations

Pacific Centre for Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

No withdrawal bleed

Withdrawal Bleed

Arm Description

No progestin prior to ovulation induction with clomiphene citrate

Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)

Outcomes

Primary Outcome Measures

Clinical pregnancy rate per ovulation

clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation

Secondary Outcome Measures

cumulative pregnancy rate

ovulation rate

ovulation rate (progesterone >10nmol/L per clomiphene cycle)

ongoing pregnancy rate

ongoing pregnancy rate (pregnancy with a fetal heartbeat >12 weeks gestational age)

miscarriage rate

multiple pregnancy rate

multiple pregnancy rate (twins and higher order multiples)

endometrial thickness

endometrial thickness (assessed via transvaginal ultrasound)

Full Information

NCT ID

NCT01966575

First Posted

September 17, 2013

Last Updated

November 4, 2014

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01966575

Brief Title

Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate

Official Title

Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Recent findings suggest that letrozole may be a superior Clomiphene Citrate.

Study Start Date

October 2013 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not produce an egg each month, resulting in irregular periods. As a result, these women often need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional 'clomiphene protocol' begins with a short course of progestin treatment to bring on a period (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence, however, has suggested that this progestin-induced shedding of the uterine lining (i.e., withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS undergoing a clomiphene cycle. It is hypothesized that patients who undergo ovulation induction with clomiphene citrate without prior endometrial shedding will have higher clinical pregnancy rates than those who begin with a progestin-induced withdrawal bleed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Infertility

Keywords

Polycystic ovary syndrome, Progestin, Endometrial shedding, Ovulation induction cycles, Clomiphene citrate, Clinical pregnancy rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No withdrawal bleed

Arm Type

Experimental

Arm Description

No progestin prior to ovulation induction with clomiphene citrate

Arm Title

Withdrawal Bleed

Arm Type

No Intervention

Arm Description

Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)

Intervention Type

Drug

Intervention Name(s)

Progestin

Other Intervention Name(s)

medroxyprogesterone acetate (MPA), i.e. Provera

Intervention Description

The experimental group will have no progestin prior to ovulation induction with clomiphene citrate, while the comparison group will have progestin medication prior to ovulation induction with clomiphene citrate, as per usual care.

Primary Outcome Measure Information:

Title

Clinical pregnancy rate per ovulation

Description

clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation

Time Frame

6 weeks after starting clomiphene

Secondary Outcome Measure Information:

Title

cumulative pregnancy rate

Description

cumulative pregnancy rate

Time Frame

assessed 9 months after the ovulation induction cycles

Title

ovulation rate

Description

ovulation rate (progesterone >10nmol/L per clomiphene cycle)

Time Frame

assessed 1 month after each induced ovulation cycle

Title

ongoing pregnancy rate

Description

ongoing pregnancy rate (pregnancy with a fetal heartbeat >12 weeks gestational age)

Time Frame

assessed 12 weeks after clinical pregnancy is acheived

Title

miscarriage rate

Description

miscarriage rate

Time Frame

Assessed 4 months after clinical pregnancy acheived

Title

multiple pregnancy rate

Description

multiple pregnancy rate (twins and higher order multiples)

Time Frame

Assessed 4 months after clinical pregnancy acheived

Title

endometrial thickness

Description

endometrial thickness (assessed via transvaginal ultrasound)

Time Frame

Assessed at 1 month after conception

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility Age 18-38 years At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year) Normal semen analysis (total motile sperm count >20million/ml) Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year) Undergoing ovulation-induction with clomiphene citrate without intra-uterine insemination (IUI) Exclusion Criteria: Body mass index (BMI) < 17 kg/m2 or > 40 kg/m2 Prior treatment with clomiphene citrate Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram) Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome Any other cause of infertility other than anovulation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jon Havelock, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pacific Centre for Reproductive Medicine

City

Burnaby

State/Province

British Columbia

ZIP/Postal Code

V5G 4X7

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate

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