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Polycystic Ovary Syndrome

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Female Urogenital Diseases and Pregnancy Complications

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N-acetyl-cysteine + Clomiphene citrate + LOD

N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling

N-acetyl-cysteine

Clomiphene citrate + Laparoscopic ovarian drilling

Clomiphene citrate

This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation, mid- luteal sub-endometrial blood flow indices, and incidence of side effects.

NAC in CC Resistant PCOS After LOD

N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial

Ain Shams University

Infertility

Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months

Ahmed Gibreel, Dr

Mohamed S Abdelhafez, Dr

The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.

IVF Versus LOD in Women With CC Resistant PCOS

In Vitro Fertilization Versus Laparoscopic Ovarian Drilling in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Number of live births divided by the number of women

Number of clinical pregnancies divided by the number of women

Number of multifetal pregnancies divided by the number of clinical pregnancies

Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Incidence of OHSS within 9 days of final triggering of oocyte maturation

Mohamed Sayed Abdelhafez

Menotropins

Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.

Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol

Gonadotropin

The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; IVF group and gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.

IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS

In Vitro Fertilization Versus Gonadotropin Therapy in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Anti-Inflammatory Agents

Antineoplastic Agents

Micronutrients

Hematinics

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Bone Density Conservation Agents

Vitamins

Prednisolone

Folic Acid

Vitamin B Complex

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Calcium

Calcium, Dietary

Chelating Agents

Glucocorticoids

Antineoplastic Agents, Hormonal

Trace Elements

Folinic Acid

Folate

Vitamin B9

Women will receive clomiphene citrate and prednisolone

Women will receive clomiphene citrate and folic acid 0.5mg (placebo)

Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)

Clomiphene citrate and Prednisolone

Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle)

Clomiphene citrate and folic acid

Mahmoud M Abdelrazik, Dr

Mahmoud Thabet, D

The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the mid-luteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle

Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS

Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Number of ovulatory cycles divided by the number of stimulation cycles

Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration

Endometrial thickness by TVS on day of HCG administration

Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women

Mahmoud Thabet

Chorionic Gonadotropin

Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)

Women will receive clomiphene citrate alone

Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)

Clomiphene citrate and Human chorionic gonadotropin (HCG)

Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)

Mahmoud Thabet, MD

Khaled S Ismael, MD

Ahmed Ragab, MD

Maged R Elshamy, MD

Mohamed A Elnegery, MD

Hamed Youssef, MD

Mahmoud M Abdel-razik, MD

Mohamed S Abdelhafez, MD

The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of HCG and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle

Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS

Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation

Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NAC in CC Resistant PCOS After LOD	NCT02775734	Clomiphene Citr...	N-acetyl-cystei... Clomiphene citr...	18 Years - 35 Years	Ain Shams University
NAC in CC Resistant PCOS After LOD	NCT02775734	Clomiphene Citr...	N-acetyl-cystei... Clomiphene citr...	18 Years - 35 Years	Ain Shams University
IVF Versus LOD in Women With CC Resistant PCOS	NCT02456792	Infertility Polycystic Ovar...	IVF LOD	20 Years - 35 Years	Mansoura University
IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS	NCT02458963	Infertility Polycystic Ovar...	IVF Gonadotropin	20 Years - 35 Years	Mansoura University
Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS	NCT02344888	Infertility Polycystic Ovar...	Clomiphene citr... Clomiphene citr...	20 Years - 35 Years	Mansoura University
IVF Versus LOD in Women With CC Resistant PCOS	NCT02456792	Infertility Polycystic Ovar...	IVF LOD	20 Years - 35 Years	Mansoura University
Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS	NCT02436226	Infertility Polycystic Ovar...	Clomiphene citr... Clomiphene citr...	20 Years - 35 Years	Mansoura University
IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS	NCT02458963	Infertility Polycystic Ovar...	IVF Gonadotropin	20 Years - 35 Years	Mansoura University

Spots Global Cancer Trial Database for clomiphene citrate resistant