Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413179
Status:
COMPLETED
Last Update Posted:
2006-12-19
First Post:
2006-12-18
Brief Title:
The Effect of Metformin Added to Clomiphene Citrate on Pregnancy Rates in Hyperandrogenic Chronic Oligoovulatory or Anovulatory Women
Sponsor:
59th Medical Wing
Organization:
59th Medical Wing
Study Overview
Official Title:
The Effect of Metformin Added to Clomiphene Citrate on Pregnancy Rates in Hyperandrogenic Chronic Oligoovulatory or Anovulatory Women A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of our study was to conduct a placebo controlled double-blind randomized trial in chronic oligoovulatory or anovulatory hyperandrogenic infertility patients comparing the effects of adjuvant metformin plus clomiphene citrate to clomiphene citrate plus placebo on pregnancy rates and ovulation rates We hypothesized that combining metformin with clomiphene citrate would result in higher ovulation and pregnancy rates in hyperandrogenic women who have chronic oligoovulation or anovulation as the sole etiology for their infertility and who have unknown responsiveness to clomiphene citrate
Detailed Description:
Women with polycystic ovary syndrome PCOS defined as chronic oligoovulation or anovulation and hyperandrogenism are primarily treated with clomiphene citrate as first line therapy if they desire pregnancy However women with PCOS have lower than expected pregnancy rates in response to clomiphene citrate Approximately 20 of women with PCOS are resistant to clomiphene citrate Subjects with chronic oligoovulation or anovulation and hyperandrogenism will ovulate 80 of the time but pregnancy occurs in only 40 The ideal initial treatment regimen for women with PCOS who desire pregnancy has not been determined
Metformin Glucophage Bristol-Myers Squibb Princeton NJ is an insulin sensitizer and lowers serum insulin and androgen levels Numerous case studies case series retrospective studies and non-placebo controlled prospective studies have suggested an improvement in insulin sensitivity spontaneous menses ovulatory response and pregnancies when metformin was given alone or prior to initiation of ovulation inducing agents in women with chronic anovulation and hyperandrogenism
However there has been conflicting evidence in the literature regarding the effect of metformin alone or in combination with ovulation inducing agents regarding ovulation and pregnancy rates in prospective randomized trials Therefore it remains unknown if the use of metformin plus clomiphene citrate in non-selected infertility patients with PCOS improves ovulation and pregnancy rates compared to the use of clomiphene citrate alone
Women with a history of infertility and diagnosed with hyperandrogenic oligoovulatory or anovulatory cycles as the sole etiology for their infertility were randomized to receive clomiphene citrate 50 mg days 5-9 plus metformin 500 mg three times daily versus clomiphene plus placebo The dose of clomiphene was increased up to a maximum dose of 250 mg in a step-wise fashion until ovulation was confirmed with an ovulation predictor kit Once ovulation was confirmed the subjects continued the ovulatory dose of clomiphene for 6 ovulatory cycles or until conception Metformin or placebo was started on cycle day one and discontinued 8 days after the LH surge andor by cycle day 21 A positive HCG ovulation rates and pregnancy outcome were the outcome measures
Metformin Glucophage Bristol-Myers Squibb Princeton NJ is an insulin sensitizer and lowers serum insulin and androgen levels Numerous case studies case series retrospective studies and non-placebo controlled prospective studies have suggested an improvement in insulin sensitivity spontaneous menses ovulatory response and pregnancies when metformin was given alone or prior to initiation of ovulation inducing agents in women with chronic anovulation and hyperandrogenism
However there has been conflicting evidence in the literature regarding the effect of metformin alone or in combination with ovulation inducing agents regarding ovulation and pregnancy rates in prospective randomized trials Therefore it remains unknown if the use of metformin plus clomiphene citrate in non-selected infertility patients with PCOS improves ovulation and pregnancy rates compared to the use of clomiphene citrate alone
Women with a history of infertility and diagnosed with hyperandrogenic oligoovulatory or anovulatory cycles as the sole etiology for their infertility were randomized to receive clomiphene citrate 50 mg days 5-9 plus metformin 500 mg three times daily versus clomiphene plus placebo The dose of clomiphene was increased up to a maximum dose of 250 mg in a step-wise fashion until ovulation was confirmed with an ovulation predictor kit Once ovulation was confirmed the subjects continued the ovulatory dose of clomiphene for 6 ovulatory cycles or until conception Metformin or placebo was started on cycle day one and discontinued 8 days after the LH surge andor by cycle day 21 A positive HCG ovulation rates and pregnancy outcome were the outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None