Effects of clomiphene citrate on endometrial morphology.

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2015011920408N3
• Date of registration: 2016-10-05
• Prospective Registration: Yes
• Primary sponsor: Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
• Public title: Effects of clomiphene citrate on endometrial morphology.
• Scientific title: Evaluation of endometrial pinopod concentrations changes during the ovulation induction by Clomiphene citrate plus Estradiol valerate and Clomiphene citrate plus Progesterone comparison with Clomiphene citrate alone among infertile women.
• Date of first enrolment: 2016-10-22
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/18103
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Other design features: Women will be divided in three tenth groups based on randomized numbers table.
• Phase: 2

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Marzieh Zamaniyan
• Affiliation: Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences,

• Name: Marzieh Zamaniyan
• Affiliation: Reproductive and Infertility Health Research Center, Shahid Beheshti University of Medical Sciences,

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: Infertile women have 35 years old and younger; regular menstrual cycles, resistant to clomiphene citrate; no previous history of in vitro fertilization; and no other causes of infertility. Exclusion criteria: Women aged over 35 years; irregular menstrual cycles; prior good response to clomiphene.
Exclusion criteria:

Age minimum: 20 years
Age maximum: 35 years
Gender: Female

Health Condition(s) or Problem(s) studied

Hyperstimulation of ovaries

Female infertility of uterine origin

Female infertility of other origin

Condition 1: Diseases of the genitourinary system. Condition 2: Diseases of the genitourinary system. Condition 3: Diseases of the genitourinary system.
Female infertility of uterine origin
Female infertility of other origin
Hyperstimulation of ovaries

Intervention(s)

Intervention 2: Clomiphene (Tab, 50 mg, oral, three times a day, on days 5-9 of menstrual cycles, Aburaihan company, Iran) plus medroxy progesterone acetate (Tab 5 mg, oral, twise daily, from day 14 until the time of biopsy on day 21 of menstrual cycles) and endometrial biopsy (Novak curette, Bonyan Atieh Darman Company, Iran) and blood sampling on day 21 of menstrual cycles

Intervention 1: Clomiphene citrate (Tab, 50 mg, oral, three times a day, on days 5-9 of menstrual cycles, Aburaihan company, Iran) plus estradiol valerate (Tab 2 mg, oral, twice daily for 5 days on day eight of menstrual cycles, Aburaihan company, Iran) and endometrial biopsy (Novak curette, Bonyan Atieh Darman Company, Iran) and blood sampling are done on day 21 of menstrual cycles

Treatment - Drugs

Intervention 1: Intervention 1: Clomiphene citrate (Tab, 50 mg, oral, three times a day, on days 5-9 of menstrual cycles, Aburaihan company, Iran) plus estradiol valerate (Tab 2 mg, oral, twice daily for 5 days on day eight of menstrual cycles, Aburaihan company, Iran) and endometrial biopsy (Novak curette, Bonyan Atieh Darman Company, Iran) and blood sampling are done on day 21 of menstrual cycles. Intervention 2: Intervention 2: Clomiphene (Tab, 50 mg, oral, three times a day, on days 5-9 of menstrual cycles, Aburaihan company, Iran) plus medroxy progesterone acetate (Tab 5 mg, oral, twise daily, from day 14 until the time of biopsy on day 21 of menstrual cycles) and endometrial biopsy (Novak curette, Bonyan Atieh Darman Company, Iran) and blood sampling on day 21 of menstrual cycles. Intervention 3: Intervention 3: Clomiphene citrate (Tab, 50 mg, oral, three times a day, on days 5-9 of menstrual cycles, Aburaihan company, Iran) and endometrial biopsy (Novak curette, Bonyan Atieh Darman Company, Iran) and blood sampling on day 21 of menstrual cycles.

Intervention 3: Clomiphene citrate (Tab, 50 mg, oral, three times a day, on days 5-9 of menstrual cycles, Aburaihan company, Iran) and endometrial biopsy (Novak curette, Bonyan Atieh Darman Company, Iran) and blood sampling on day 21 of menstrual cycles

Primary Outcome(s)

Endometrial concentrations of pinopod. Timepoint: On 21 of cycles. Method of measurement: Questionnaire.

Secondary Outcome(s)

Progesterone concentrations. Timepoint: On 21 of menstrual cycles. Method of measurement: Progesterone laboratory kit.

Estrogen concentrations. Timepoint: On day 21 of menstrual cycles. Method of measurement: Estrogen laboratory kit.

Source(s) of Monetary Support

Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Shahid Beheshti University of Medical Sciences.