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Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles

Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles. A Randomized Controlled Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04008966
Enrollment
160
Registered
2019-07-05
Start date
2016-07-20
Completion date
2019-07-01
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assisted Reproduction

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.

Interventions

PROCEDUREEmbryo transfer

Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter

400 mg twice daily per vagina

PROCEDUREOvum pick up

34 hours after triggering under the guidance of transvaginal ultrasound

DRUGcombined oral contaraceptive pills

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

DRUGUrinaru 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

DRUGGnRH antagonist

0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering

DRUGHuman 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

DRUGGnRH 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 42 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
number of mature follicular count10 - 14 days of the cyclenumber of follicles larger than 14 mm

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026