Invitro Fertilization Clinical Trial
Official title:
Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI
Verified date | November 2017 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 204 |
Est. completion date | November 3, 2017 |
Est. primary completion date | November 1, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 39 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ahmed Maged | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | chemical pregnancy rate | POSITIVE pregnancy testing of HCG exceeding 50 mIU | 14 days after embryo transfer | |
Secondary | abortion rate | termination of pregnancy before 12 weeks of gestational age | 12 weeks of gestational age | |
Secondary | Ovarian hyperstimulation syndrome | 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 | |
Secondary | Late Ovarian hyperstimulation syndrome | OHSS manifestation 12 to 17 days following HCG administration | 12 to 17 days following HCG administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03684824 -
Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment
|
N/A | |
Not yet recruiting |
NCT03683043 -
Comparative Study Between ICSI Results in Transvaginal Ultrasound Guided Embryo Transfer and Transabdominal Ultrasound Guided Embryo Transfer
|
Phase 4 | |
Recruiting |
NCT02329197 -
Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure
|
Phase 4 | |
Completed |
NCT02764255 -
Embryoscope and Reproductive Outcome
|
N/A | |
Recruiting |
NCT02084940 -
Long Acting GnRH Antagonist in PCOS Women Undergoing IVF
|
N/A | |
Completed |
NCT02674178 -
FSH/LH Ratio as a Predictor of IVF Outcome in Young and Older Women
|
Phase 4 | |
Completed |
NCT01576991 -
Telomeres and Reproduction in Women
|
N/A | |
Recruiting |
NCT03457233 -
The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles
|
N/A | |
Completed |
NCT02660125 -
Endometrial Injury and Implantation Rates Before First ICSI Cycle
|
N/A | |
Completed |
NCT03402620 -
Poor Responders Infertile Patients -A Great Clinical Challenge
|
N/A | |
Completed |
NCT03831542 -
Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization
|
||
Not yet recruiting |
NCT03263299 -
Value of Cabergoline and Low Dose Aspirin in Poor Responders Undergoing ICSI-ET With GnRH Agonist Flare-Up-Protocol
|
Phase 4 | |
Recruiting |
NCT02383394 -
Factors Associated With Pregnancy Loss in IVF Women
|
N/A |