Comparison of Clomiphene and Letrozole in association with Metfomin in patients with anovulation

Metformin-Letrozole in comparison with Metfomin-Clomiphene citrate in infertile clomiphene resistant polycystic ovary patients undergoing intrauterine insemination

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138807262604N1

Enrollment

100

Registered

2011-01-16

Start date

2007-04-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility. Polycystic ovarian syndrome

Interventions

Intervention 1: Metformin 1500mg/day for 6-8 weeks then Metformin + Clomiphene 100mg for 5 days from third day of cycle. Intervention 2: Metformin 1500 mg/day for 6-8 weeks then Metformin + Letrozole

Treatment - Drugs

Metformin 1500mg/day for 6-8 weeks then Metformin + Clomiphene 100mg for 5 days from third day of cycle

Metformin 1500 mg/day for 6-8 weeks then Metformin + Letrozole 5 mg/day for 5 days from third day of cycle

Eligibility

Sex/Gender

Female

Age

19 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: polycystic ovary syndrome, Clomiphene resistant, normal liver function, normal kidney function, normal thyroid function. Exclusion criteria: use of Clomiphene in previous 2 months, use of metformin in previous 2 months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Endometrial thickness on day of HCG administration. Timepoint: one time in each cycle. Method of measurement: distance between two layer endometrium measured by sonography.;Estrogen level on day of HCG administration. Timepoint: one time in each cycle. Method of measurement: measurement of estrogen in serum.;Number of follicles>18mm. Timepoint: every other day from cycle day 12. Method of measurement: by counting of follicles more than18 millimeter in sonography.;Chemical pregnancy. Timepoint: 2 weeks after IUI. Method of measurement: by measurement of HCG level in serum.;Clinical prgnancy. Timepoint: one time in each cycle. Method of measurement: observation of gestational sac in sonography.	—

Measure

Time frame

Endometrial thickness on day of HCG administration. Timepoint: one time in each cycle. Method of measurement: distance between two layer endometrium measured by sonography.;Estrogen level on day of HCG administration. Timepoint: one time in each cycle. Method of measurement: measurement of estrogen in serum.;Number of follicles>18mm. Timepoint: every other day from cycle day 12. Method of measurement: by counting of follicles more than18 millimeter in sonography.;Chemical pregnancy. Timepoint: 2 weeks after IUI. Method of measurement: by measurement of HCG level in serum.;Clinical prgnancy. Timepoint: one time in each cycle. Method of measurement: observation of gestational sac in sonography.

—

Secondary

Measure	Time frame
Abortion rate. Timepoint: one time in each treatment cycle. Method of measurement: observation of expulsion of product of conception from uterous, disappearance of gestational sac in sonography, HCG level in serum dropped or become negative.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRobab Davar M.D.

Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences

davar@ssu.ac.ir , r_davar@yahoo.com+98 35 1824 7085

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026