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The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes

Dual Trigger With Gonadotropin-releasing Hormone Agonist (GnRHa) and Human Chorionic Gonadotropin (hCG) to Optimize ICSI Reproductive Outcomes

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01979341
Enrollment
0
Registered
2013-11-08
Start date
2013-10-31
Completion date
2016-09-30
Last updated
2016-05-26

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

Conditions

Ovarian Hyperstimulation Syndrome, Pregnancy

Keywords

dual trigger, hCG, GnRH agonist, ICSI, pregnancy, OHSS

Brief summary

The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole use results in reduced embryo implantation due to luteal phase insufficiency. The combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to overcome the luteal phase insufficiency effecting endometrial receptivity. In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in normoresponders will increase oocyte maturity, embryo quality and embryo implantation and reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose) alone trigger.

Interventions

PROCEDUREfinal oocyte maturation trigger

when ≥3 follicles reach 17mm patients will be randomized to receive one of two types of trigger for final oocyte maturation; dual trigger: GnRH agonist plus hCG (both full doses) hCG only: full dose of hCG only

Sponsors

Antalya IVF
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

* Age; \< 40 years * Cycle number; cycles 1 or 2 * Antral follicle count; \>10 and \<25 * BMI; \>18 and \<30 * Normogonadotrophic cycle length; 24 to 25 days * Male; ejaculated semen only

Exclusion criteria

* Presence of endocrine disorders; (diabetes mellitus, hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome) * Previous major uterine surgery (that would affect endometrial receptivity) Secondary

Design outcomes

Primary

MeasureTime frameDescription
embryo implantation rate12 monthsthe number of fetal sacs per embryo transferred to a patient's uterus

Secondary

MeasureTime frameDescription
oocyte maturation12 monthsthe percentage of oocytes that are at the metaphase II (nuclear mature) stage at the time of oocyte collection
Ovarian hyperstimulation syndrome12 monthsa complication arising from ovarian hyperstimulation with the use of exogenous hormones and ovulation induction

Other

MeasureTime frameDescription
clinical pregnancy12 monthsthe number of patients with an ultrasound confirmed fetal heart 7 weeks after the transfer of embryos to patient uteruses

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026