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

NCTNCT03118830Other id164

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 204 participants (actual)
Sponsor: Cairo University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Egypt
Start: 21 Apr 2017
Primary completion: 1 Nov 2017
Completion: 3 Nov 2017
First posted: 18 Apr 2017
Last update posted: 7 Nov 2017
Conditions: Invitro Fertilization

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20172018

Ph 4
Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI
NCT03118830
21 Apr 2017 to 3 Nov 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TriptorelinDrug
cetrorelixDrug
Recombinant Follicle Stimulating HormoneDrug

Arms2

Active comparator
Long GnRH agonist
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
Active comparator
GnRH antagonist
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

Primary outcomes1

Outcomes the sponsor listed as primary.

clinical pregnancy rate
Time frame · 4 weeks after embryo transfer
Registry description
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)

Secondary outcomes(4)

chemical pregnancy rate
Time frame · 14 days after embryo transfer
Registry description
POSITIVE pregnancy testing of HCG exceeding 50 mIU
abortion rate
Time frame · 12 weeks of gestational age
Registry description
termination of pregnancy before 12 weeks of gestational age
Ovarian hyperstimulation syndrome
Time frame · 7 days after HCG administration
Registry description
evaluated by the British fertility society criteria, the Canadian Fertility and Andrology Society ( CFAS) and the Society of obstetrics and Gynecology of Canada (SOGC); \[Mild OHSS; Abdominal bloating, Mild abdominal pain, Ovarian size usually \< 8 cm. Moderate OHSS; Moderate abdominal pain, Nausea with/without vomiting, Ultrasound evidence of ascites and Ovarian size usually 8-12 cm. Severe OHSS; Clinical ascites (occasionally pleural effusion), Oliguria, Hemoconcentration with hematocrit (\> 45%), Hypoproteinemia and Ovarian size usually \> 12 cm. Critical OHSS; Tense ascites or large pleural effusion, Hematocrit (\> 55%) White cell count \> 25 000/L, anuria, Thromboembolism or Acute respiratory distress syndrome
Late Ovarian hyperstimulation syndrome
Time frame · 12 to 17 days following HCG administration
Registry description
OHSS manifestation 12 to 17 days following HCG administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 20 Years up to 39 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. PCOS diagnosed by Roterdam criteria 2. Protocol used for ovulation induction either long procol with freeze all embryos vs antagonist with fresh embryo transfer 3. BMI less than 30 4. 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 Exclusion criteria; 1. PCOS on long protocol with fresh embryo transfer and those on antagonist protocol with freezing all embryo 2. BMI more than 30 3. PCOS patients not given adjuvant drugs in prophylaxis of OHSS 4. Antagonist cases receiving agonist as trigger instead of HCG 5. PCOS receiving more than 5000 IU HCG as trigger 6. PCOS undergoing costing during ovulation induction 7. PCOS with known medial problems as diabetes or hypertension

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