Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI

NCT03118830 | Completed Phase 4 DMC

• 1 other identifier: 164
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be divided into two groups Group A; patients using long protocol and freeze all embryos Group B; patients using antagonist protocol with fresh embryo transfer Patients will be carefully chosen according to a strict inclusion and exclusion criteria after meticulous revision of patient files. In the long protocol, daily SC injection of Triptorelin :Decapeptyl 0.1 mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG triggering. Gn stimulation started after fulfilling stimulation start criteria of thin endometrium \< 5 mm and low E2 \< 50 and LH \< 5IU/l with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a starting dose of 150-300 IU/day according to women age, day 3 FSH,AMH and previous gonadotropin response then adjustment of the dose according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day (6) for folliculometry and endometrial thickness and pattern. Triggering by HCG 10000 IU IM (Pregnyl, Organon, the Netherlands) when 2 or more follicles have 18 mm as a mean diameter . Flexible GnRH antagonist protocol was done with daily s.c administration of cetrorelix 0.25 mg (Cetrotide, Merck Serono, Darmstadt, Germany) started when one or more of the following criteria were achieved: (i) one or more follicle reached 14 mm diameter; (ii) The level of serum E2 reached 600 pg/ml; and (iii) The level of serum LH levels reached 10 IU/l . Daily sc rFSH (Gonal-f; Merck Serono , Darmstadt, Germany) injections was started on 2nd day of the cycle in the antagonist protocol. Continuation of rFSH and GnRH antagonist daily until triggering day was done.

Conditions

Invitro Fertilization

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  The detection of fetal cardiac activity within a gestational sac on ultrasonography examinationenlargement (\<12 cm in average diameter), ascitis in moderate form and clinical evidence of ascites and/or hydrothorax, haemoconcentration and significant ovarian enlargement (\>12 cm in average diameter)

  4 weeks after embryo transfer

Secondary Outcomes (4)

• chemical pregnancy rate

  14 days after embryo transfer

• abortion rate

  12 weeks of gestational age

• Ovarian hyperstimulation syndrome

  7 days after HCG administration

• Late Ovarian hyperstimulation syndrome

  12 to 17 days following HCG administration

Study Arms (2)

Long GnRH agonist

ACTIVE COMPARATOR

daily SC injection of Triptorelin :Decapeptyl 0.1 mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG triggering. Gn stimulation started after fulfilling stimulation start criteria of thin endometrium \< 5 mm and low E2 \< 50 and LH \< 5IU/l with either HMG or rFSH in a starting dose of 150-300 IU/day

Drug: Triptorelin; Drug: Recombinant Follicle Stimulating Hormone

GnRH antagonist

ACTIVE COMPARATOR

Flexible GnRH antagonist protocol was done with daily s.c administration of cetrorelix 0.25 mg started when one or more of the following criteria were achieved: (i) one or more follicle reached 14 mm diameter; (ii) The level of serum E2 reached 600 pg/ml; and (iii) The level of serum LH levels reached 10 IU/l. Daily sc rFSH injections was started on 2nd day of the cycle in the antagonist protocol. Continuation of rFSH and GnRH antagonist daily until triggering day was done

Drug: cetrorelix; Drug: Recombinant Follicle Stimulating Hormone

Interventions

Triptorelin DRUG

daily SC injection of Triptorelin 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG triggering.

Also known as: Decapeptyl

Long GnRH agonist

cetrorelix DRUG

Flexible GnRH antagonist protocol was done with daily s.c administration of cetrorelix 0.25 mg started when one or more of the following criteria were achieved: (i) one or more follicle reached 14 mm diameter; (ii) The level of serum E2 reached 600 pg/ml; and (iii) The level of serum LH levels reached 10 IU/l .

Also known as: Cetrotide

GnRH antagonist

Recombinant Follicle Stimulating Hormone DRUG

Daily sc rFSH (Gonal-f; Merck Serono , Darmstadt, Germany) injections was started on 2nd day of the cycle in the antagonist protocol. Continuation of rFSH and GnRH antagonist daily until triggering day was done.

Also known as: Gonal-f

GnRH antagonist; Long GnRH agonist

Eligibility Criteria

• Age: 20 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS diagnosed by Roterdam criteria
• Protocol used for ovulation induction either long procol with freeze all embryos vs antagonist with fresh embryo transfer
• BMI less than 30
• ALL patients receiving adjuvant drugs for prevention of OHSS in the form of metformin, cabergoline as well as prophylactic hysteril , low dose asprin and LMW heparin following oocyte retrieval on a routine basis

You may not qualify if:

• PCOS on long protocol with fresh embryo transfer and those on antagonist protocol with freezing all embryo
• BMI more than 30
• PCOS patients not given adjuvant drugs in prophylaxis of OHSS
• Antagonist cases receiving agonist as trigger instead of HCG
• PCOS receiving more than 5000 IU HCG as trigger
• PCOS undergoing costing during ovulation induction
• PCOS with known medial problems as diabetes or hypertension

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Maged

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

Triptorelin Pamoate; cetrorelix; Glycoprotein Hormones, alpha Subunit; follitropin alfa

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Chorionic Gonadotropin; Gonadotropins; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 18, 2017
• Study Start: April 21, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 3, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)