Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: single trigger 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection |
Drug: combined oral contaraceptive pills
1 tablet daily between days 5 and 25 of the cycle before stimulation
Other Names:
Drug: recombinant FSH
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
Drug: Urinaru gonadotropin
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
Drug: GnRH antagonist
0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering
Other Names:
Drug: Human chorionic gonadotropin
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
Procedure: Ovum pick up
34 hours after triggering under the guidance of transvaginal ultrasound
Procedure: Embryo transfer
Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter
Drug: natural Progesterone
400 mg twice daily per vagina
Other Names:
|
| Active Comparator: Dual trigger 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 |
Drug: combined oral contaraceptive pills
1 tablet daily between days 5 and 25 of the cycle before stimulation
Other Names:
Drug: recombinant FSH
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
Drug: Urinaru gonadotropin
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
Drug: GnRH antagonist
0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering
Other Names:
Drug: Human chorionic gonadotropin
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
Drug: GnRH agonist
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
Other Names:
Procedure: Ovum pick up
34 hours after triggering under the guidance of transvaginal ultrasound
Procedure: Embryo transfer
Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter
Drug: natural Progesterone
400 mg twice daily per vagina
Other Names:
|
Outcome Measures
Primary Outcome Measures
- number of mature follicular count [10 - 14 days of the cycle]
number of follicles larger than 14 mm
Eligibility Criteria
Criteria
Inclusion Criteria:
-
women with poor ovarian response candidate for ICSI
-
women with spontaneous normal menstrual cycle
-
normal uterine cavity
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasr Alainy medical school | Cairo | Egypt | 12151 |
Sponsors and Collaborators
- Cairo University
Investigators
- Principal Investigator: Ahmed maged, MD, Professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 58