Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles
Condition: Assisted Reproduction
Study type: Interventional
Phase: Phase 4

Summary: 
      All participants started with a combination of recombinant FSH 300 U and urinary Gn 150 U
      from the 2nd day of the cycle then the dose was adjusted according to the ovarian response

      From day 6 of the cycle, follow up using transvaginal ultrasound was done either daily or on
      alternate days according to the ovarian response. When the leading follicle reached 12 mm,
      GnRH antagonist was started using Cetrotide 0.25 subcutaneously daily till the day of
      triggering. Triggering was done when at least 3 follicles larger than 14 mm and at least one
      of them reached a mean diameter of 17 mm or more.

      At the day of triggering, women were randomized into 2 groups. Group I (single trigger group)
      that included 80 women who received triggering in the form of 10,000 IU of HCG intramuscular
      injection. Group II (Dual trigger group) that included 80 women who received triggering in
      the form of 10,000 IU of HCG intramuscular injection in addition to GnRH agonist triptorelin
      0.2 mg subcutaneously.

      Ovum pickup was done 34 hours after triggering under the guidance of transvaginal ultrasound.

      ISM1 culture medium was used for oocyte collection and embryo culture. Transabdominal
      ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect
      semirigid catheter by the same expert operator

      Cycle cancellation was done if day 9 folliculometry revealed less than 2 mature follicles, no
      oocytes were retrieved or if fertilization failed

      Luteal phase support was started in all women on the day of oocyte retrieval and continued
      till the day of serum β-hCG assessment (done 14 days after ET) through administration of 400
      mg of natural Progesterone twice daily per vagina . In women with +ve serum β-hCG (> 5
      mIU/ml), transvaginal ultrasound evaluation was done 4 weeks after ET to confirm the presence
      and number of intrauterine gestational sacs.
    

Detailed description: 
      All participants started with a combination of recombinant FSH 300 U and urinary Gn 150 U
      from the 2nd day of the cycle then the dose was adjusted according to the ovarian response
      evaluated by transvaginal ultrasound and serum E2. Delayed start

      From day 6 of the cycle, follow up using transvaginal ultrasound was done either daily or on
      alternate days according to the ovarian response. Ultrasound follow up reported number and
      size of follicles in each ovary and the endometrial thickness and pattern. When the leading
      follicle reached 12 mm, GnRH antagonist was started using Cetrotide 0.25 subcutaneously daily
      till the day of triggering. Triggering was done when at least 3 follicles larger than 14 mm
      and at least one of them reached a mean diameter of 17 mm or more.

      At the day of triggering, women were randomized into 2 groups. Group I (single trigger group)
      that included 80 women who received triggering in the form of 10,000 IU of HCG intramuscular
      injection. Group II (Dual trigger group) that included 80 women who received triggering in
      the form of 10,000 IU of HCG intramuscular injection in addition to GnRH agonist triptorelin
      0.2 mg subcutaneously.

      Ovum pickup was done 34 hours after triggering under the guidance of transvaginal ultrasound.

      ISM1 culture medium was used for oocyte collection and embryo culture. Transabdominal
      ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect
      semirigid catheter by the same expert operator

      Cycle cancellation was done if day 9 folliculometry revealed less than 2 mature follicles, no
      oocytes were retrieved or if fertilization failed

      Luteal phase support was started in all women on the day of oocyte retrieval and continued
      till the day of serum β-hCG assessment (done 14 days after ET) through administration of 400
      mg of natural Progesterone twice daily per vagina . In women with +ve serum β-hCG (> 5
      mIU/ml), transvaginal ultrasound evaluation was done 4 weeks after ET to confirm the presence
      and number of intrauterine gestational sacs.
    

Intervention name(s): combined oral contaraceptive pills; recombinant FSH; Urinaru gonadotropin; GnRH antagonist; Human chorionic gonadotropin; GnRH agonist; Ovum pick up; Embryo transfer; natural Progesterone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Drug
Intervention description(s): 1 tablet daily between days 5 and 25 of the cycle before stimulation; 300 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2; 150 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2; 0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering; 10,000 IU intramuscular when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more; 0.2 mg subcutaneously when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more; 34 hours after triggering under the guidance of transvaginal ultrasound; Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter; 400 mg twice daily per vagina
Other intervention name(s): Gynera; Cetrotide; triptorelin; Prontogest
Intervention MeSH terms: Triptorelin Pamoate; Chorionic Gonadotropin; Cetrorelix; Progesterone; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment