Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles
NCT ID: NCT04008966
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2016-07-20
2019-07-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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single trigger
80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection
combined oral contaraceptive pills
1 tablet daily between days 5 and 25 of the cycle before stimulation
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
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
GnRH antagonist
0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering
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
Ovum pick up
34 hours after triggering under the guidance of transvaginal ultrasound
Embryo transfer
Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter
natural Progesterone
400 mg twice daily per vagina
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
combined oral contaraceptive pills
1 tablet daily between days 5 and 25 of the cycle before stimulation
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
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
GnRH antagonist
0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering
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
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
Ovum pick up
34 hours after triggering under the guidance of transvaginal ultrasound
Embryo transfer
Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter
natural Progesterone
400 mg twice daily per vagina
Interventions
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combined oral contaraceptive pills
1 tablet daily between days 5 and 25 of the cycle before stimulation
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
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
GnRH antagonist
0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering
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
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
Ovum pick up
34 hours after triggering under the guidance of transvaginal ultrasound
Embryo transfer
Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter
natural Progesterone
400 mg twice daily per vagina
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* women with spontaneous normal menstrual cycle
* normal uterine cavity
Exclusion Criteria
* endometriosis
* hydrosalpinx
* endocrinological disorders as hyperprolactinemia, thyroid or adrenal disorders.
* Couples with azospermic male partner
* those with severe uncontrolled medical or metabolic disorders
25 Years
42 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed M Maged, MD
professor
Principal Investigators
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Ahmed maged, MD
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Kasr Alainy medical school
Cairo, , Egypt
Countries
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References
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Maged AM, Ragab MA, Shohayeb A, Saber W, Ekladious S, Hussein EA, El-Mazny A, Hany A. Comparative study between single versus dual trigger for poor responders in GnRH-antagonist ICSI cycles: A randomized controlled study. Int J Gynaecol Obstet. 2021 Mar;152(3):395-400. doi: 10.1002/ijgo.13405. Epub 2020 Oct 22.
Other Identifiers
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58
Identifier Type: -
Identifier Source: org_study_id
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