PregnancyNCT01979341

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

A study testing final oocyte maturation trigger in people with Pregnancy and Ovarian Hyperstimulation Syndrome, run by Antalya IVF at 1 site in Turkey (Türkiye).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy, Ovarian Hyperstimulation Syndrome
What is being tested?: final oocyte maturation trigger
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Oct 2013to Sep 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Antalya IVF
Antalya, Antalya, 07080

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions: Pregnancy, Ovarian Hyperstimulation Syndrome
Being tested: final oocyte maturation trigger
Keywords: dual trigger, hCG, GnRH agonist, ICSI, pregnancy, OHSS
Medical subject headings: Ovarian Hyperstimulation Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

final oocyte maturation triggerProcedure or surgery
Also called 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)
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

Study groups in NCT01979341
Study group	Role	What they receive
Dual trigger	Active comparator	final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist) Receives: Procedure: final oocyte maturation trigger
hCG trigger	Active comparator	final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) Receives: Procedure: final oocyte maturation trigger
agonist trigger	Active comparator	final oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist) Receives: Procedure: final oocyte maturation trigger

What is being measured

The primary outcome is the main question the study is designed to answer.

embryo implantation rate
the number of fetal sacs per embryo transferred to a patient's uterus
Measured: 12 months

Secondary outcomes (2)

oocyte maturation
the percentage of oocytes that are at the metaphase II (nuclear mature) stage at the time of oocyte collection
Measured: 12 months
Ovarian hyperstimulation syndrome
a complication arising from ovarian hyperstimulation with the use of exogenous hormones and ovulation induction
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Sep 2016

First posted8 Nov 2013 (estimated)
Study startOct 2013
Primary completionJun 2016 (estimated)
Study completionSep 2016 (estimated)

Why it stopped: treatment strategy changed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PregnancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01979341
Sponsor's protocol ID: AntalyaIVF-RCT-dual trigger
Other IDs: App. No. 01042013/103
Status last verified: May 2016
First submitted: 1 Nov 2013
Last updated: 26 May 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dual Trigger With Gonadotropin-releasing Hormone Agonist (GnRHa) and Human Chorionic Gonadotropin (hCG) to Optimize ICSI Reproductive Outcomes
ClinicalTrials.gov ID: NCT01979341
Acronym / sponsor ID: AntalyaIVF-RCT-dual trigger
Conditions: Pregnancy, Ovarian Hyperstimulation Syndrome
Keywords: dual trigger, hCG, GnRH agonist, ICSI, pregnancy, OHSS
Study type: Interventional
Recruitment status: WithdrawnReason stopped: treatment strategy changed
Enrolment: 0 participants (actual)
Lead sponsor: Antalya IVFUniversity, hospital or other
Study start: Oct 2013
Primary completion: Jun 2016 (estimated)
Study completion: Sep 2016 (estimated)
First posted: 8 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Dual trigger	Active comparator	Procedure: final oocyte maturation triggerfinal oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)
hCG trigger	Active comparator	Procedure: final oocyte maturation triggerfinal oocyte maturation trigger using 6500 IU Ovitrelle (hCG)
agonist trigger	Active comparator	Procedure: final oocyte maturation triggerfinal oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist)

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
final oocyte maturation triggerAlso: 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)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	Procedure or surgery	Dual trigger, agonist trigger, hCG trigger

Primary outcome

embryo implantation rate
Time frame: 12 months
the number of fetal sacs per embryo transferred to a patient's uterus

2 secondary outcomes

oocyte maturation
Time frame: 12 months
Ovarian hyperstimulation syndrome
Time frame: 12 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hasan Bulut, MD principal investigator

Antalya IVF

Kemal Ozgur, MD principal investigator

Antalya IVF

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing final oocyte maturation trigger in people with Pregnancy and Ovarian Hyperstimulation Syndrome, run by Antalya IVF at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

embryo implantation rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01979341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.