- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03118830
Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Cycle cancellation was decided when transvaginal ultrasound scan on cycle day (9) revealed no adequate follicular growth (<3 mature follicles),if no oocytes were retrieved on ovum pick up,or if failure of fertilization occurred. If signs of early OHSS were observed at 3rd day of ovum pickup ,cancellation of ET was done with elective embryo cryopreservation as it may end with life-threatening OHSS . ET was cancelled also if any criteria of hospital admission was found
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 12151
- Ahmed Maged
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion criteria;
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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.
Other Names:
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.
Other Names:
|
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
|
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.
Other Names:
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 .
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical pregnancy rate
Time Frame: 4 weeks after embryo transfer
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
chemical pregnancy rate
Time Frame: 14 days after embryo transfer
|
POSITIVE pregnancy testing of HCG exceeding 50 mIU
|
14 days after embryo transfer
|
abortion rate
Time Frame: 12 weeks of gestational age
|
termination of pregnancy before 12 weeks of gestational age
|
12 weeks of gestational age
|
Ovarian hyperstimulation syndrome
Time Frame: 7 days after HCG administration
|
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
|
7 days after HCG administration
|
Late Ovarian hyperstimulation syndrome
Time Frame: 12 to 17 days following HCG administration
|
OHSS manifestation 12 to 17 days following HCG administration
|
12 to 17 days following HCG administration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Fertility Agents, Female
- Fertility Agents
- Luteolytic Agents
- Follicle Stimulating Hormone
- Hormones
- Triptorelin Pamoate
- Cetrorelix
Other Study ID Numbers
- 164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Invitro Fertilization
-
Cairo UniversityUnknown
-
Cairo UniversityCompleted
-
Cairo UniversityCompleted
-
Cairo UniversityUnknown
-
Cairo UniversityUnknown
-
Cairo UniversityUnknown
-
Cairo UniversityUnknownInvitro FertilizationEgypt
-
Cairo UniversityCompleted
Clinical Trials on Triptorelin
-
Nanjing UniversityUnknownPolycystic Ovary Syndrome | In Vitro FertilizationChina
-
Aristotle University Of ThessalonikiEugonia IVF Unit, Athens, GreeceUnknown
-
ChenshilingNational Natural Science Foundation of China; Comprehensive Strategic Cooperation... and other collaboratorsUnknown
-
IVI MadridCompletedOvarian Hyperstimulation SyndromeSpain
-
Masaryk UniversityMinistry of Health, Czech RepublicCompletedHodgkin Disease | Hodgkin LymphomaCzech Republic
-
Universitair Ziekenhuis BrusselUniversitaire Ziekenhuizen KU LeuvenRecruitingBreast Cancer FemaleBelgium
-
Kaunas University of MedicineUnknown
-
Tampere University HospitalCompleted
-
Parc de Salut MarCompletedHealthy VolunteersSpain