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Second-Line Treatments for Anovulatory Infertility in PCOS Patients

Primary Purpose

Polycystic Ovary Syndrome, Infertility, Anovulation

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Metformin plus clomiphene citrate

Laparoscopic ovarian drilling

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Anovulation, Clomiphene citrate, Fertility, Metformin, Ovulation induction, PCOS, Sterility, Treatment, Clomiphene citrate-resistance

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

PCOS
Clomiphene citrate-resistance
Anovulation
Infertility

Exclusion Criteria:

Age < 18 or > 35 years
Body mass index >35
Neoplastic, metabolic, endocrine, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses
Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs affecting hormone levels, carbohydrate metabolism, or appetite
Pelvic diseases
Previous pelvic surgery
Suspected peritoneal factor infertility/subfertility
Tubal or male factor infertility or sub-fertility

Sites / Locations

"Pugliese" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Metformin plus clomiphene citrate

Laparoscopic ovarian drilling

Outcomes

Primary Outcome Measures

Live-birth rate

Secondary Outcome Measures

Spontaneous menses

Pregnancy rate

Abortion rate

Full Information

NCT ID

NCT00558077

First Posted

November 13, 2007

Last Updated

November 13, 2007

Sponsor

University Magna Graecia

1. Study Identification

Unique Protocol Identification Number

NCT00558077

Brief Title

Second-Line Treatments for Anovulatory Infertility in PCOS Patients

Official Title

Laparoscopic Ovarian Diathermy or Metformin Plus Clomiphene Citrate Administration as Second-Line Treatment for Infertile Anovulatory Patients With Polycystic Ovary Syndrome: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Magna Graecia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To date, it is still unclear the potential role of laparoscopic ovarian diathermy (LOD) in the management of polycystic ovary syndrome (PCOS)-related anovulatory infertility. Metformin administration, alone or combined with clomiphene citrate (CC), has shown to be an effective and attractive second-line treatment for ovulation induction in women with polycystic ovary syndrome (PCOS) after failure of CC treatment. The aim of the present study will be to compare in a randomized controlled fashion the efficacy of LOD with metformin plus CC administration in the treatment of the CC-resistant PCOS patients.

Detailed Description

A total of 50 primary infertile anovulatory PCOS patients with documented CC-resistance will be enrolled and randomized into two groups of treatment of 25 subjects each. Group A will undergo diagnostic laparoscopy followed by metformin plus CC, whereas group B will undergo LOD followed by observation. Anovulatory patients will receive IM progesterone. The treatment will be of six months followed by nine-month of observation for pregnant patients. The incidence of spontaneous menses, and the pregnancy, abortion, and live-birth rates will be recorded.

6. Conditions and Keywords

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

Polycystic Ovary Syndrome, Infertility, Anovulation

Keywords

Anovulation, Clomiphene citrate, Fertility, Metformin, Ovulation induction, PCOS, Sterility, Treatment, Clomiphene citrate-resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Metformin plus clomiphene citrate

Arm Title

Arm Type

Active Comparator

Arm Description

Laparoscopic ovarian drilling

Intervention Type

Drug

Intervention Name(s)

Metformin plus clomiphene citrate

Intervention Description

Metformin administration will start from 3rd day of a P-induced withdrawal bleeding with a dose of 850 mg (1 tablet daily) and increasing the dosage after one week up to 1700 mg/day (two tablets daily). Clomiphene citrate CC will be administered for five days beginning on cycle day 3rd of a P-induced withdrawal bleeding using a starting dose of 50 mg daily. If ovulation will not occur, the dose will be increased by 50 mg in successive cycles until the ovulation will be achieved or up to a maximal dose of 150 mg daily.

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic ovarian drilling

Intervention Description

Laparoscopic ovarian drilling will be performed as follows: according to ovary size three to six punctures will be performed at each ovary inserting an insulated needle cautery of 36 mm perpendicularly as possible to the ovarian surface with a cutting current of 100 watt power. Then, the needle will be activated for 2-3 seconds at each point using a coagulating current of 40 watt power. At completion of the procedure, the ovarian surface will be washed with a crystalloid solution and all injured areas will be completely covered with hyaluronic acid gel.

Primary Outcome Measure Information:

Title

Live-birth rate

Time Frame

fifteen months

Secondary Outcome Measure Information:

Title

Spontaneous menses

Time Frame

six months

Title

Pregnancy rate

Time Frame

six months

Title

Abortion rate

Time Frame

fifteen months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: PCOS Clomiphene citrate-resistance Anovulation Infertility Exclusion Criteria: Age < 18 or > 35 years Body mass index >35 Neoplastic, metabolic, endocrine, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs affecting hormone levels, carbohydrate metabolism, or appetite Pelvic diseases Previous pelvic surgery Suspected peritoneal factor infertility/subfertility Tubal or male factor infertility or sub-fertility

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefano Palomba, MD

Organizational Affiliation

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fulvio Zullo, MD

Organizational Affiliation

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Official's Role

Study Chair

Facility Information:

Facility Name

"Pugliese" Hospital

City

Catanzaro

State/Province

Catanzaro/Italy

ZIP/Postal Code

88100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

15840746

Citation

Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.

Results Reference

background

PubMed Identifier

15472166

Citation

Palomba S, Orio F Jr, Nardo LG, Falbo A, Russo T, Corea D, Doldo P, Lombardi G, Tolino A, Colao A, Zullo F. Metformin administration versus laparoscopic ovarian diathermy in clomiphene citrate-resistant women with polycystic ovary syndrome: a prospective parallel randomized double-blind placebo-controlled trial. J Clin Endocrinol Metab. 2004 Oct;89(10):4801-9. doi: 10.1210/jc.2004-0689. Erratum In: J Clin Endocrinol Metab. 2005 Jul;90(7):3945.

Results Reference

background

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Second-Line Treatments for Anovulatory Infertility in PCOS Patients

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