Trigger Time in Advanced Maternal Age Patients With Low AMH

NCT03740880 | Terminated DMC

• 1 other identifier: 1810-ABU-067-HF
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

the Number of Mature Oocytes

Keywords

ICSI; early trigger; poor ovarian responders; low AMH

Outcome Measures

Primary Outcomes (1)

• the number of mature oocytes

  A mature oocyte is defined as an oocyte that has extruded his first polar body and this mature oocyte is ready to be fertilized by the participants sperm.

  1 day

Secondary Outcomes (9)

• Maturation rate

  1 day

• Fertilization rate

  1 day

• Embryo development up to day 3

  3 days

• Blastulation rate

  7 days

• Embryo development up to day 5

  7 days

Other Outcomes (5)

• Controlled ovarian stimulation: dosage

  2 weeks

• Controlled ovarian stimulation: days of stimulation

  2 weeks

• Controlled ovarian stimulation: hormonal profile

  2 weeks

Study Arms (2)

Late trigger

ACTIVE COMPARATOR

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

Other: Dual trigger

Early trigger

EXPERIMENTAL

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

Other: Dual trigger

Interventions

Dual trigger OTHER

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

Early trigger; Late trigger

Eligibility Criteria

• Age: 40 Years - 48 Years
• Gender Eligibility Details: only female patients can undergo an ovarian stimulation protocol
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• weeks OCP followed by
• a wash out of 5 days (without OCP) followed by

You may not qualify if:

• 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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

IVI RMA Abu Dhabi

Abu Dhabi, United Arab Emirates

Location

Related Publications (4)

• Haahr T, Esteves SC, Humaidan P. Individualized controlled ovarian stimulation in expected poor-responders: an update. Reprod Biol Endocrinol. 2018 Mar 9;16(1):20. doi: 10.1186/s12958-018-0342-1.

  PMID: 29523204 RESULT

• Oudendijk JF, Yarde F, Eijkemans MJ, Broekmans FJ, Broer SL. The poor responder in IVF: is the prognosis always poor?: a systematic review. Hum Reprod Update. 2012 Jan-Feb;18(1):1-11. doi: 10.1093/humupd/dmr037. Epub 2011 Oct 10.

  PMID: 21987525 RESULT

• Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.

  PMID: 21505041 RESULT

• Beckers NG, Macklon NS, Eijkemans MJ, Fauser BC. Women with regular menstrual cycles and a poor response to ovarian hyperstimulation for in vitro fertilization exhibit follicular phase characteristics suggestive of ovarian aging. Fertil Steril. 2002 Aug;78(2):291-7. doi: 10.1016/s0015-0282(02)03227-2.

  PMID: 12137865 RESULT

Study Officials

• Neelke De Munck, PhD

  IVIRMA Abu Dhabi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 14, 2018
• Study Start: January 7, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 30, 2020
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

AE (1)