NCT03400722

Brief Summary

Patients with infertility of the older age group of 37-42 years - a large cohort of patients of reproductive medicine. Two possible causes reduce their probability of pregnancy - an increasing age and a decrease of the ovarian reserve. In these conditions, the early receipt of embryos for future transfer can serve as a correct strategy for treating infertility in this category of patients. According to statistical data, patients of the 37-42-year-old age group need 3-5 blastocysts, out of them 1-2 euploid to achieve pregnancy. The POSEIDON group of researchers identified a group of 2b patients with a suboptimal response to the induction of superovulation in IVF programs - patients older than 35 years with a normal ovarian reserve (the number of antral follicles greater than 5 and Anti-Müllerian hormone (AMH) greater than 1.2 ng / ml), resulting in 4-9 oocytes after a standard ovarian stimulation. In this situation standard stimulation protocols can stretch the process of obtaining embryos indefinitely, during which the patient will move to another age category with a decrease in the likelihood of pregnancy. Thus, these patients are shown the fastest reception of oocytes and the accumulation of embryos, which can be done using double ovarian stimulation in the same menstrual cycle. The aim of the study is to compare the different schemes of double stimulation in patients with infertility of the older age group of 37-42 years with the preceding suboptimal response. Group 1 - patients of the DUOSTIM group. Group 2 - Patients of the Shanghai Protocol. The investigated parameters - primary outcome measures: total number of retrieved oocytes per cycle, secondary outcome measures: total number of blastocyst per cycle, number of cycles with double ovarian stimulation required to obtain 3-5 blastocyst, time until embryo transfer, pregnancy rate and birth rate This is a prospective randomized non-blinded clinical study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

December 19, 2017

Last Update Submit

January 14, 2018

Conditions

Infertility, FemaleOvarian StimulationIn Vitro Fertilisation

Keywords

Suboptimal ovarian responseOvarian StimulationInfertility, FemaleIn Vitro Fertilisation

Outcome Measures

Primary Outcomes (1)

  • Total number of retrieved oocytes per cycle

    evaluation the total number of retrieved oocytes after double ovarian stimulation in one cycle

    up to 9 months

Secondary Outcomes (5)

  • total number of blastocyst per cycle

    up to 9 months

  • Time until embryo transfer

    up to 9 months

  • number of cycles need to treat

    up to 9 months

  • pregnancy rate

    up to 9 months

  • the birth rate

    up to 18 months

Study Arms (2)

DUOSTIM group

EXPERIMENTAL

Pergoveris 150 -300 IU start from day 2 of the cycle up to the day of trigger, GnRH antagonist 0,25 mg start from day 7-8 of the cycle up to the day of trigger, final trigger of ovarian stimulation - GnRH-a 0,2 mg, oocyte retrieval 35 hours after trigger, stop period for 5 days, after stop period start Pergoveris 150 - 300 IU start up to the day of trigger, GnRH antagonist 0,25 mg start from day 6 of ovarian stimulation up to the day of trigger, final trigger of ovarian stimulation - GnRH-a 0,2 mg, oocyte retrieval 35 hours after trigger. After oocyte retrieval fertilization will be carried out by IVI or ICSI, the development of embryos will be carried out up to blastocyst stage, then blastocyst vitrification will be performed.

Drug: Pergoveris

Modified Shanghai Protocol group

EXPERIMENTAL

Clomiphene 50 mg start from day 2-3 of the cycle up to the day of trigger, Pergoveris 150 - 300 IU - 6,8, 10 days of the cycle, final trigger of ovarian stimulation - GnRH-a 0,2 mg, oocyte retrieval 35 hours after trigger, after stop period for 2-3 days start Pergoveris 150 - 300 IU up to the day of trigger, final trigger of ovarian stimulation - GnRH-a 0,2 mg, oocyte retrieval 35 hours after trigger. After oocyte retrieval fertilization will be carried out by IVI or ICSI, the development of embryos will be carried out up to blastocyst stage, then blastocyst vitrification will be performed.

Drug: Clomiphene

Interventions

PergoverisDRUG

Two controlled ovarian stimulation within the same menstrual cycle. It will be followed by ovarian puncture, fertilisation of oocyte by IVI or ICSI, blastocyst vitrification. If there are 3-5 blastocysts, the embryo accumulation process will be completed and the unfrozen embryos transferred.

Also known as: antagonist of gonadotropin releasing hormone, agonist of gonadotropin releasing hormone
DUOSTIM group
ClomipheneDRUG

Two controlled ovarian stimulation within the same menstrual cycle. It will be followed by ovarian puncture, fertilisation of oocyte by IVI or ICSI, blastocyst vitrification. If there are 3-5 blastocysts, the embryo accumulation process will be completed and the unfrozen embryos transferred.

Also known as: Pergoveris, agonist of gonadotropin releasing hormone
Modified Shanghai Protocol group

Eligibility Criteria

Age37 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • BMI 18-30 kg\\m2
  • Suboptimal ovarian responders with normal ovarian reserve: the number of antral follicles greater than 5 and AMH greater than 1.2 ng / ml, resulting in 4-9 oocytes after a standard ovarian stimulation, according Poseidon classification - group 2b
  • Informed consent

You may not qualify if:

  • Medical contraindications for IVF
  • Basal follicle stimulating hormone (FSH) more 15 IU/L
  • Severe mail factor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irina Zorina

Moscow, 119048, Russia

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

pergoverisClomiphene

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Konstantin Dancheev

    MEDINSERVIS LLC NOVA CLINIC

    STUDY DIRECTOR

Central Study Contacts

Irina Zorina, M.D.,Ph.D.

CONTACT

+79263407621irinazorina@yandex.ru

Irina Zorina, M.D.,Ph.D.

CONTACT

+74952211188i.zorina@nova-clinic.ru

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 17, 2018

Study Start

December 1, 2017

Primary Completion

August 1, 2018

Study Completion

May 1, 2019

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

RU(1)