Trigger Time in Advanced Maternal Age Patients With Low AMH

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2020-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators want to verify if advanced maternal age patients with a low Anti-Müllerian hormone (AMH) level may benefit from an early trigger time (compared to a late trigger).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins

NCT02237781

Female Infertility

UNKNOWN PHASE2/PHASE3

Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles

NCT04407065

Infertility, Female

UNKNOWN PHASE2

Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

NCT04224818

Poor Ovarian Reserve

COMPLETED PHASE3

Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF

NCT02173977

Infertility

UNKNOWN PHASE2

AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol

NCT01762111

Infertility

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

During assisted reproduction, patients are stimulated in order to achieve a multifollicular development. The final step in this stimulation process is "the trigger" that will induce the final maturation of the oocytes. This timing is historically put once at least one follicle of 16-17 mm is obtained.

When looking at poor ovarian responder (POR) patients (characterized by a low AMH), the investigators observe shorter menstrual cycles and thus it is thought that the oocyte selected for ovulation, will also mature faster. This observation may indicate that POR patients potentially do not benefit from a trigger performed once a leading follicle of 17 mm is present, but rather from an earlier trigger.

The main objective is to analyse if an early trigger (leading follicle of 14 mm) results in the same maturation rate in POR patient as compared to a late trigger (17 mm). As the embryos will be cultured in a time lapse imaging system, annotations on the developmental kinetics can be made and the differences in fertilization rate and embryo development can be analysed as secondary outcome parameter. On top of this, patients will undergo a genetic testing of their embryos and this genetic analysis , together with the mtDNA copy number will also be compared between patients with early or late trigger. Euploid blastocysts will be transferred in subsequent frozen embryo transfer (FET) cycles and give an indication on the clinical outcome between IVF and ICSI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

the Number of Mature Oocytes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups: 1 groups of patients receiving an early trigger (14mm), the other group receiving a late trigger (17mm)

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Late trigger

dual trigger (10.000 IU hCG i.m. and 0.3 mg Deca) once the leading follicle is 17 mm

Group Type ACTIVE_COMPARATOR

Dual trigger

Intervention Type OTHER

dual trigger: 10.000 IU hCG i.m. and 0.3 mg Deca

Early trigger

dual trigger (10.000 IU hCG i.m. and 0.3 mg Deca) once the leading follicle is 14 mm

Group Type EXPERIMENTAL

Dual trigger

Intervention Type OTHER

dual trigger: 10.000 IU hCG i.m. and 0.3 mg Deca

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dual trigger

dual trigger: 10.000 IU hCG i.m. and 0.3 mg Deca

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • POR defined according to the Bologna criteria:

* AMA: ≥40 years and AMH \<1.1 ng/ml
* Previous poor ovarian response with maximum 3 cumulus oocyte complexes retrieved after conventional stimulation
* Antral follicle count \< 5-7

* Cycling patients
* Fresh ejaculates
* ICSI
* BMI 19-32 kg/m2
* Ovarian stimulation protocol: Antagonist HMG 450 IU to ensure all receptors are covered and to ensure maximum recruitment. Dose adjustments can be made after 5 days of stimulation
* Type of trigger for final oocyte maturation: dual trigger: 10.000 IU hCG i.m. and 0.3 mg Deca
* Couples requesting preimplantation genetic testing (for aneuploidies) of their embryos
* Follicular measurements should be performed at IVI RMA Fertility, Abu Dhabi, UAE: a single operator will perform the ultrasound for the final measurement before trigger. Recruitment can be done by all physicians
* Only patients with an oral contraceptive pill (OCP) pretreatment to synchronize follicular development:
* 2 weeks OCP followed by
* a wash out of 5 days (without OCP) followed by

* o start stimulation
* Basal hormone profile (FSH, LH, E2, P4) measured between day 1-3 at IVIRMA Fertility, Abu Dhabi, UAE
* FSH \<15 IU
* E2 \<50 pg/ml
* P \<1ng/ml

* Only the Arab population
* Oocyte retrieval: 36 hours after trigger
* PGT-A

Exclusion Criteria

* If follicular measurement before randomization shows a leading follicle ≥ 13mm
* IVF
* History of:

* Endometriosis AFS\>2
* Chemotherapy/radiotherapy
* Ovarian surgery (iatrogenic)
* Cyst puncture in the last three months
* Sonographic finding of:

* Hydrosalpinx
* Ovarian cyst
* Testicular samples and frozen ejaculates
* If patients are pre-screened at the start of stimulation but no follicular development is observed, patients will not be randomized
* Asynchronized follicular development at the moment of randomization: if the leading follicle is \>3 mm lager than the smaller follicles.
* All other hormonal pretreatments (except OCP) and all patients without hormonal pretreatment

Minimum Eligible Age

40 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes