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

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy Ovarian Hyperstimulation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dual trigger

final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)

Group Type ACTIVE_COMPARATOR

final oocyte maturation trigger

Intervention Type PROCEDURE

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

hCG trigger

final oocyte maturation trigger using 6500 IU Ovitrelle (hCG)

Group Type ACTIVE_COMPARATOR

final oocyte maturation trigger

Intervention Type PROCEDURE

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

agonist trigger

final oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist)

Group Type ACTIVE_COMPARATOR

final oocyte maturation trigger

Intervention Type PROCEDURE

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

Interventions

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final 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

Intervention Type PROCEDURE

Other Intervention Names

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dual trigger: 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist) hCG trigger: 6500 IU Ovitrelle (hCG) agonist trigger: 0.2mg triptorelin acetate (GnRH agonist)

Eligibility Criteria

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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)

* \<5 follicles at the time of trigger
* \<2 full formed blastocyst on day 5 of embryo culture

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes