Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI
Condition: Invitro Fertilization
Study type: Interventional
Phase: Phase 4

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.
    

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
    

Intervention name(s): Triptorelin; cetrorelix; Recombinant Follicle Stimulating Hormone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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 (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 intervention name(s): Decapeptyl; Cetrotide; Gonal-f
Intervention MeSH terms: Triptorelin Pamoate; Cetrorelix; Hormones; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment