Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles
- Conditions
- Assisted Reproduction
- Interventions
- Drug: combined oral contaraceptive pillsDrug: Urinaru gonadotropinProcedure: Embryo transferProcedure: Ovum pick up
- Registration Number
- NCT04008966
- Lead Sponsor
- Cairo University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- women with poor ovarian response candidate for ICSI
- women with spontaneous normal menstrual cycle
- normal uterine cavity
- women with ovarian cysts
- endometriosis
- hydrosalpinx
- endocrinological disorders as hyperprolactinemia, thyroid or adrenal disorders.
- Couples with azospermic male partner
- those with severe uncontrolled medical or metabolic disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description single trigger combined oral contaraceptive pills 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection single trigger recombinant FSH 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection single trigger Urinaru gonadotropin 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection single trigger GnRH antagonist 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection single trigger Embryo transfer 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection single trigger natural Progesterone 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection Dual trigger combined oral contaraceptive pills 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 Dual trigger recombinant FSH 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 Dual trigger Urinaru gonadotropin 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 Dual trigger GnRH antagonist 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 Dual trigger Ovum pick up 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 Dual trigger Embryo transfer 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 single trigger Ovum pick up 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection Dual trigger natural Progesterone 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 Dual trigger GnRH agonist 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 single trigger Human chorionic gonadotropin 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection Dual trigger Human chorionic gonadotropin 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
- Primary Outcome Measures
Name Time Method number of mature follicular count 10 - 14 days of the cycle number of follicles larger than 14 mm
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kasr Alainy medical school
🇪🇬Cairo, Egypt