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Citrate

Carnitine

This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test.

This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test.

Clomiphene Citrate 50mg

L-carnitine

Placebo Oral Tablet

Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance

Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

visible intra-uterine gestational sac, with a positive fetal heart beat, viewed during a transvaginal ultrasound (when the b-hCG concentration was more than 1500 IU/l)

Assiut University

Principal investigator

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.

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

Adel S Salah El-Din, MD

adel S salah el-din, MD

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.

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 .

Clomiphene Citrate Stair-Step Protocol

Clomiphene Citrate Stair-step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome: A Randomized Clinical Trial

* Follicle suddenly disappears or regresses in size.
* Irregular margins.
* Intra follicular echos. Follicle suddenly becomes more echogenic.
* Free fluid in pouch of douglas.

the total dose of clomiphene used till ovulation

Ain Shams Maternity Hospital

Assistant professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome	NCT03630341	Polycystic Ovar...	Clomiphene Citr... L-carnitine Placebo Oral Ta...	18 Years - 35 Years	Assiut University
Clomiphene Citrate Stair-Step Protocol	NCT03178500	Polycystic Ovar...	Clomiphene Citr...	20 Years - 35 Years	Ain Shams Maternity Hospital

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