Clomiphene Citrate Stair-Step Protocol

Ain Shams Maternity Hospital

Status: Unknown

Conditions: Polycystic Ovary

Treatments: Drug: Clomiphene Citrate 50mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03178500

STAIRSTEP TRIAL

Details and patient eligibility

About

A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation induction with the stair-step protocol. Sixty women will be included after obtaining their written informed consent and will be randomized into either of the 2 groups.

Full description

This study is a randomized clinical trial (RCT) will be conducted in Ain Shams University maternity hospital at infertility clinic within a period of 6-8 months.

All patient are previously diagnosed as PCOs according to the Rotterdam conference of 2003.

All patients will be devided according to computer based program into two groups First group: Patients with traditional protocol

Traditional protocol:

Clomiphene citrate (clomid) (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded if no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles .

Second group: Patient with stair step protocol Follicular development will be monitored using transvaginal ultrasound at 11-14 day after (50mg) clomiphene for 5 days if there is no response (no follicle >10mm), so, (100mg) clomiphene will be initiated immediately for 5 days and ultrasound will be repeated 1 week after the first ultrasound. If there is no response, (150mg) clomiphene will be initiated immediately for another 5 days and TV/US will be performed 1 week after the second TV/US .

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 20-35 years.

  • Body mass index (BMI/m2) 26-35 kg/m2
  • Normal hystrosalpingogram (HSG).
  • Normal Prolactin level.
  • Normal semen analysis.

Exclusion criteria

• • They underwent ovarian drilling.
• Other factors infertility.
• AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Traditional

Experimental group

Description:

Clomiphene citrate (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded. If no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles.

Treatment:

Drug: Clomiphene Citrate 50mg

Stair step protocol

Experimental group

Description:

If there is no response (no follicle \>10mm), so, (100mg) clomiphene will be initiated immediately for 5 days and ultrasound will be repeated 1 week after the first ultrasound. If there is no response, (150mg) clomiphene will be initiated immediately for another 5 days and TV/US will be performed 1 week after the second TV/US

Treatment:

Drug: Clomiphene Citrate 50mg