Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Genital Diseases

Urogenital Diseases

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Ovarian Diseases

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Genital Diseases, Female

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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All Drugs and Chemicals

Antineoplastic Agents

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Hormones

Follicle Stimulating Hormone

Mitogens

Triptorelin Pamoate

Cetrorelix

Chorionic Gonadotropin

Menotropins

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Antineoplastic Agents, Hormonal

Hormone Antagonists

The pituitary down-regulation in this group will be carried out using 0.05-0.1 mg of Triptorelin acetate subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the menstrual cycle until the ovulation triggering day. When the suppressive effect is obtained, ovarian stimulation will commence with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) and the dose will be adjusted according to the ovarian response. Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

The ovarian stimulation in this group will be started with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) on the third day of the menstrual cycle and the dose will be adjusted according to the ovarian response. Initiation of 0.25 mg of GnRH antagonist; Cetrorelix; will take place after detecting a leading follicle diameter ≥ 14 mm. GnRH antagonist administration will be continued till the day of ovulation triggering, which will be accomplished by given 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.

Triptorelin acetate

0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.

Dosage adjustment according to the ovarian response.

recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin

Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm.

Human Chorionic Gonadotropin (hCG)

Sally Kadoura, B Pharm, MD

Abdul Hakim Nattouf, MD, PhD

Marwan Alhalabi, MD, PhD

This prospective, non-randomised, open-label, clinical trial is conducting on polycystic ovary syndrome (PCOS) subjects to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on clinical and embryological IVF/ICSI outcomes, and on the follicular fluid levels of Placental Growth Factor (PlGF); which is known for his pivotal role in the regulation of ovulation, embryo development, and implantation

Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until assayed using an Elisa kit.

The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration 35±2 hours after hCG administration.

The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.

Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes.

Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes.

Cleavage rate is calculated by dividing the number of cleavaged embryos by the number of zygotes (2PN).

Embryos are assessed using Nikon SMZ1500 stereoscope based on ESHRE criteria (2011).

High Quality Embryos rate is calculated by dividing the number of high quality embryos (Grade I) by the total number of cleavaged embryos.

Biochemical pregnancy is defined as a positive serum beta-hCG pregnancy test after 2 weeks of embryo transfer. The biochemical pregnancy rate is calculated by dividing the number of women who are biochemically pregnant by the number of women who have at least 1 embryo transferred.

Clinical pregnancy is defined as the presence of a gestational sac on ultrasound after 3-4 weeks of embryo transfer. The clinical pregnancy rate is calculated as by dividing the number of women who are clinically pregnant divided by the number of women who have at least 1 embryo transferred.

Damascus University

Micronutrients

Hematinics

Vitamins

Other Dietary Supplements

Inositol

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

60 patients diagnosed with PCOS, not myo-inositol treated undergoing ICSI

52 patients diagnosed with PCOS undergoing ICSI, taking Inofolic (myo-inositol + folic acid)

105 patients not diagnosed with PCOS undergoing ICSI, not taking myo-inositol

4000 mg of myo-inositol and 0,4 mg of folic acid for 3 months preceding the ICSI procedure

Inofolic: myo-inositol and folic acid

The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate, embryo development dynamics and oestradiol and progesterone concentration in blood serum and Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).

Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment

Evaluation Concerning the Influence of Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment

The decision was taken when three conditions are met: the biggest oocyte exceeds 17mm, the endometrium was over 9mm (two layers) and estradiol level was greater than 150

Embryo culture was evaluated by means of constant monitoring performed in 10-minute intervals with a camera placed inside the incubator.The t0 time was described as the hour of the ICSI. tF was defined as the first moment when pronuclei were already visible, whereas tC as the last moment of their visibility. The moment when a single cell embryo appeared after syngamy was determined as t1, and then the superseding divisions were marked as t2, t3, t4, t5, t6, t7, t8. tM stood for the beginning of morula formation, whereas tB was the time during which the first signs of blastocyst cavity could be seen.

Ultrasound examination of the echo of the embryo and heart rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.	NCT04727671	In Vitro Fertil... Intracytoplasmi... Infertility Polycystic Ovar...	Triptorelin ace... Cetrorelix recombinant-FSH... Human Chorionic...	18 Years - 39 Years	Damascus University
Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment	NCT02385396	Polycystic Ovar... Infertility	Inofolic: myo-i...	27 Years - 35 Years	Medical University of Lublin
Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment	NCT02385396	Polycystic Ovar... Infertility	Inofolic: myo-i...	27 Years - 35 Years	Medical University of Lublin

Spots Global Cancer Trial Database for intracytoplasmic sperm injection