Progestin-primed Ovarian Stimulation Protocol Versus GnRH Antagonist Protocol in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Cycles

NCT05112692 | Unknown

• 1 other identifier: PPOS in ICSI for PCOS
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to compare the efficacy and safety of the PPOS protocol to the GnRH antagonist protocol in patients with PCOS who are undergoing IVF/ICSI cycles.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Keywords

Progestin; ICSI; antagonist

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  clinical pregnancy is defined as presence of gestational sac on ultrasound performed at 6 weeks after ET. A clinical pregnancy rate is defined as number of clinical pregnancies divided by number of ET procedures.

  6 weeks after embryo transfer

Secondary Outcomes (5)

• the incidence of premature LH surges

  trigger day

• fertilization rate

  baseline

• implantation rate

  baseline

• ongoing pregnancy rate

  baseline

• live birth rate

  baseline

Study Arms (2)

PPOS group

ACTIVE COMPARATOR

Patients will be coadministered with Human Menopausal Gonadotrophin (HMG) 150-225 international unit/day (IU/d) via intramuscular injection and oral DYG 20mg/d from menstrual cycle day 3 (MC3) to the day of triggering. The starting dose of HMG is 150IU/day for patients with a high antral follicle count \>20 or slightly elevated basal FSH (7-10IU/L), and a daily dose of 225IU HMG is used for the other patients. The dose will be adjusted after day 5 of stimulation based on the ovarian response as assessed by serum hormone levels and transvaginal ultrasonography

Drug: Dydrogesterone Tablets; Drug: human menopausal gonadotropin; Drug: triptorelin 0.1 mg; Drug: human chorionic gonadotropin; Procedure: cryopreservation; Drug: Estradiol Valerate and progesterone

GnRH antagonist

ACTIVE COMPARATOR

In the fixed GnRH antagonist protocol, daily s.c. administration of Cetrotide 0.25 mg will be initiated at 6th day of stimulation. HMG (150-225IU) will be administered daily from menstrual cycle day 3, and follicular monitoring will be performed every 2 to 3 days after 5 days of injections. The dose of hMG will be adjusted according to the ovarian response, as monitored by ultrasonography and the measurement of serum sex steroids. Treatment with hMG and GnRH antagonist will continue daily until the day when final oocyte maturation is triggered

Drug: cetrorelix 0.25mg; Drug: human menopausal gonadotropin; Drug: triptorelin 0.1 mg; Drug: human chorionic gonadotropin; Procedure: cryopreservation; Drug: Estradiol Valerate and progesterone

Interventions

Dydrogesterone Tablets DRUG

first arm will be coadministered gonadotrophins with 20mg dydrogesterone till day of trigger second arm will be subjected to fixed GnRH antagonist protocol then will do Freeze All in both arms then frozen embryo transfer next cycle

PPOS group

cetrorelix 0.25mg DRUG

In the fixed GnRH antagonist protocol, daily s.c. administration of Cetrotide 0.25 mg will be initiated at 6th day of stimulation. HMG (150-225IU) will be administered daily from menstrual cycle day 3.

GnRH antagonist

human menopausal gonadotropin DRUG

(150-225IU) will be administered daily from menstrual cycle day 3 till day ot trigger

GnRH antagonist; PPOS group

triptorelin 0.1 mg DRUG

When the dominant follicles reach a diameter of 18mm, the final stage of oocyte maturation will be induced with injections of 100µg of triptorelin s.c combined with 1000IU of hCG i.m

GnRH antagonist; PPOS group

human chorionic gonadotropin DRUG

When the dominant follicles reach a diameter of 18mm, the final stage of oocyte maturation will be induced with injections of 100µg of triptorelin s.c combined with 1000IU of hCG i.m

GnRH antagonist; PPOS group

cryopreservation PROCEDURE

All of the follicles greater than 10mm in diameter will be aspirated. The oocytes are inseminated approximately 4-6hours after follicular aspiration by a conventional IVF method or intracytoplasmic sperm injection, based on the sperm quality On day 3, high quality embryos are cryopreserved by means of vitrification

GnRH antagonist; PPOS group

Estradiol Valerate and progesterone DRUG

Endometrium will be prepared using step-up oral estrogen protocols. On day 14 of estrogen administration, endometrial thickness will be assessed and serum progesterone level will be measured, with cycles to be cancelled according to the arbitrary thresholds of 7.0 mm and 1.5 ng/mL, respectively. Progesterone administration will be started on the morning (am) of day 15, with the start date of progesterone and the day of blastocyst cryopreservation used to coordinate the day of FET

GnRH antagonist; PPOS group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who have a history of infertility ≥1year.
• Ages between 20 and 35 years.
• Patients diagnosed with PCOS according to the revised 2003 Rotterdam consensus and met 2 out of 3 criteria as follows (Rotterdam, 2004):
• Oligo- and/or anovulation.
• Biochemical and/or clinical evidence of hyperandrogenism.
• Polycystic ovarian morphology on ultrasound (the presence of ≥12 antral follicles (≤9mm) and/or ovarian volume \>10mL on transvaginal ultrasonographic scanning).
• Other etiologies of hyperandrogenism and ovulatory dysfunction will be excluded, including androgen-secreting tumors, congenital adrenal hyperplasia, hyperprolactinemia and thyroid disease.

You may not qualify if:

• Endometriosis grade 3 or higher.
• Documented ovarian failure, including basal FSH above 10IU/L.
• Clinically significant systemic disease, or other endocrine disorders, including 21-hydroxylase deficiency, uncorrected thyroid disease or suspected Cushing's syndrome.
• Patients who in the previous 3 months received hormonal treatments or other medications known to affect reproductive function, including oral contraceptives and GnRH agonists.
• Documented history of ovarian surgery including laparoscopic ovarian drilling, ovarian endometrioma stripping and unilateral oophorectomy
• Previous diagnosis of congenital (septate uterus, duplex uterus, uterus bicornis and uterus unicornis) or acquired (intrauterine adhesion, submucosal myomas and adenomyosis) uterine anomalies
• History of recurrent spontaneous abortion, defined as three or more previous spontaneous pregnancy losses
• Abnormal chromosomal karyotype in either of the partners.
• Inability to comply with the study procedures.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Dydrogesterone; cetrorelix; Menotropins; Triptorelin Pamoate; Chorionic Gonadotropin; Cryopreservation; Estradiol; Progesterone

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Oligopeptides; Nerve Tissue Proteins; Proteins; Placental Hormones; Pregnancy Proteins; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Pregnenediones; Pregnenes; Corpus Luteum Hormones; Progesterone Congeners

Central Study Contacts

Ahmed Elawady, MD

CONTACT

01091474582; megivemefromme@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 9, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 9, 2021

Record last verified: 2021-10