Embryo/Fetus DeathPhase 4EmbryoscopeNCT01760278

Assessment of Implantation Potential of Embryos by Time-lapse Technology

A Phase 4 study testing recombinant Follicle Stimulating Hormone (rFSH) in people with Embryo/Fetus Death and Blastocyst Disintegration, run by Bloom IVF and Fertility Centre at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

1. Culture conditions of developing embryos are highly controlled in the Embryoscope and are monitored by Time-lapse videography to produce 3D images at different stages.This cannot be done under conventional culture conditions. 2. Read more about this study

Who is it for?: Ages 21 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for: Embryo/Fetus Death, Blastocyst Disintegration, Aneuploidy
What is being tested?: recombinant Follicle Stimulating Hormone (rFSH)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteIndia
Study dates: Dec 2012to Apr 2013
Phase: Phase 4
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 21 to 39 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women of age 21-39 yrs.
Basal FSH < 12mIU/ml
Anterior mullerian hormone(AMH) > 1.0 ng/ML
Antral follicle count (AFC) > 8
Body mass index (BMI) < 35 mt2/kg
Estradiol (E2) < 50PG/ML

Who cannot join

Women with one ovary.
Women in whom both ovaries are not seen on ultrasonography.
Women with too small uterine cavity.
Women with history of recurrent pregnancy loss
Women with systemic lupus erythematosus (SLE), Nephrotic syndrome, Meyer Rocky Tansky Kustner Hammer(MRKH) syndrome,etc.
Human immunodeficiency virus (HIV) I and II positive women.

Trial locations and contacts

1 site in 1 country.

India1 site

Lilavati Hospital and Research Center, IVF department
Mumbai, Maharashtra, 400050

Other trials in India

About this study

Official title: Assessment of Implantation Potential of Embryos Cultured by Time-lapse Technology (Embryoscope) Before Transfer in In-vitro Fertilization (IVF) / Intracytoplasmic Sperm Injection (ICSI) Cycles: A Randomized Control Study.

Culture conditions of developing embryos are highly controlled in the Embryoscope and are monitored by Time-lapse videography to produce 3D images at different stages.This cannot be done under conventional culture conditions.
The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the Embryoscope,through latest software.
Embryoviewer also identifies embryos for transfer, freezing and to be discarded.

Read the detailed description

There will be two arms of the study. The Study arm in which embryos of patients will be cultured in the Embryoscope. The control arm in which the embryos of patients will be cultured under conventional conditions.
Embryos to be transferred will be identified by the Embryoviewer in the Study arm and the ones in the control arm will be identified by established subjective morphological criteria.
Embryos with definite implantation potential will be transferred in both arms.
Embryos not transferred will be frozen and/or discarded in both arms.

Conditions: Embryo/Fetus Death, Blastocyst Disintegration, Aneuploidy, Complication of Implant, Chemical Pregnancy
Being tested: recombinant Follicle Stimulating Hormone (rFSH)
Keywords: Time-lapse monitoring of embryos., Embryoscope, IVF-ET/ICSI, Cetrorelix, Gonal-F
Medical subject headings: Stillbirth, Embryo Loss, Aneuploidy

What participants receive

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

recombinant Follicle Stimulating Hormone (rFSH)Drug
Also called Gonal-F, Progesterone vaginal, Ovitrell 250mcg, Cetrorelix 0.25 mg
There are two arms of the study. The Study arm and the Control arm. In each arm, subjects, after randomization, will be stimulated with rFSH 225IU/day.
On day 6, Cetrorelix 0.25mg/day to be added till the day of Ovitrell. Thereafter, ovum pick-up and embryo transfer to be done. Six weeks after transfer clinical pregnancy identified which will be the end-point of the study.

Study groups in NCT01760278
Study group	Role	What they receive
Study Arm	Experimental	Subjects would receive recombinant Follicle Stimulating Hormone (rFSH) by S.C. injection 150 - 225 IU/day for 9 days. The embryos of subjects would be cultured by time-lapse imagery technique (embryoscope) and analysis would be done using patients receive rFSH (Gonembryo viewer equipped with latest software. Receives: Drug: recombinant Follicle Stimulating Hormone (rFSH)
Control Arm	Active comparator	Subjects would receive recombinant Follicle Stimulating Hormone (rFSH) by S.C. injection 150 - 225 IU/day for 9 days. The embryos of subjects would be cultured in conventional culture environment and analysis would be done using established subjective morphological criteria. Receives: Drug: recombinant Follicle Stimulating Hormone (rFSH)

What is being measured

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

No.of top quality embryos produced in both the arms, study arm and control arm.
1. 4-cell embryos on day 2 of fertilization in both,Study arm and Control arm.
2. 8-cell embryos on day 3 of fertilization in both Study arm and Control arm.
3. Blastocyst embryos on day 5 or day 6 of fertilization in both Study arm and Control arm.
Measured: 2 weeks

Secondary outcomes (1)

Clinical pregnancy
Clinical pregnancy will be identified by presence of gestational sac(s) and fetal heart-beat by transvaginal ultrasonography in sixth week after embryo transfer.
Measured: 6 weeks after embryo transfer (ET)

Timeline

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

Dec 2012Apr 2013

First posted4 Jan 2013 (estimated)
Study startDec 2012
Primary completionMar 2013 (estimated)
Study completionApr 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Embryo/Fetus DeathStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01760278
Sponsor's protocol ID: Time-lapse monitoring
Other IDs: Study of embryo morphokinetics
Acronym: Embryoscope
Status last verified: Jan 2013
First submitted: 26 Dec 2012
Last updated: 4 Jan 2013
Results posted: No
Data monitoring committee: Yes

Publications

Lemmen JG, Agerholm I, Ziebe S. Kinetic markers of human embryo quality using time-lapse recordings of IVF/ICSI-fertilized oocytes. Reprod Biomed Online. 2008 Sep;17(3):385-91. doi: 10.1016/s1472-6483(10)60222-2.
PubMed 18765009

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Implantation Potential of Embryos Cultured by Time-lapse Technology (Embryoscope) Before Transfer in In-vitro Fertilization (IVF) / Intracytoplasmic Sperm Injection (ICSI) Cycles: A Randomized Control Study.
ClinicalTrials.gov ID: NCT01760278
Acronym / sponsor ID: Embryoscope / Time-lapse monitoring
Conditions: Embryo/Fetus Death, Blastocyst Disintegration, Aneuploidy, Complication of Implant, Chemical Pregnancy
Keywords: Time-lapse monitoring of embryos., Embryoscope, IVF-ET/ICSI, Cetrorelix, Gonal-F
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: Bloom IVF and Fertility CentreUniversity, hospital or other
Collaborators: Padmashree Dr. D. Y. Patil Medical College
Study start: Dec 2012
Primary completion: Mar 2013 (estimated)
Study completion: Apr 2013 (estimated)
First posted: 4 Jan 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.

Culture conditions of developing embryos are highly controlled in the Embryoscope and are monitored by Time-lapse videography to produce 3D images at different stages.This cannot be done under conventional culture conditions.
The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the Embryoscope,through latest software.
Embryoviewer also identifies embryos for transfer, freezing and to be discarded.

Detailed description

There will be two arms of the study. The Study arm in which embryos of patients will be cultured in the Embryoscope. The control arm in which the embryos of patients will be cultured under conventional conditions.
Embryos to be transferred will be identified by the Embryoviewer in the Study arm and the ones in the control arm will be identified by established subjective morphological criteria.
Embryos with definite implantation potential will be transferred in both arms.
Embryos not transferred will be frozen and/or discarded in both arms.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Study Arm	Experimental	Drug: recombinant Follicle Stimulating Hormone (rFSH)Subjects would receive recombinant Follicle Stimulating Hormone (rFSH) by S.C. injection 150 - 225 IU/day for 9 days. The embryos of subjects would be cultured by time-lapse imagery technique (embryoscope) and analysis would be done using patients receive rFSH (Gonembryo viewer equipped with latest software.
Control Arm	Active comparator	Drug: recombinant Follicle Stimulating Hormone (rFSH)Subjects would receive recombinant Follicle Stimulating Hormone (rFSH) by S.C. injection 150 - 225 IU/day for 9 days. The embryos of subjects would be cultured in conventional culture environment and analysis would be done using established subjective morphological criteria.

Who may qualify

Ages: 21 to 39 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Women of age 21-39 yrs.
Basal FSH < 12mIU/ml
Anterior mullerian hormone(AMH) > 1.0 ng/ML
Antral follicle count (AFC) > 8
Body mass index (BMI) < 35 mt2/kg

Key exclusion criteria (6 listed)

Women with one ovary.
Women in whom both ovaries are not seen on ultrasonography.
Women with too small uterine cavity.
Women with history of recurrent pregnancy loss
Women with systemic lupus erythematosus (SLE), Nephrotic syndrome, Meyer Rocky Tansky Kustner Hammer(MRKH) syndrome,etc.

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
recombinant Follicle Stimulating Hormone (rFSH)Also: Gonal-F, Progesterone vaginal, Ovitrell 250mcg, Cetrorelix 0.25 mgThere are two arms of the study. The Study arm and the Control arm. In each arm, subjects, after randomization, will be stimulated with rFSH 225IU/day. On day 6, Cetrorelix 0.25mg/day to be added till the day of Ovitrell. Thereafter, ovum pick-up and embryo transfer to be done. Six weeks after transfer clinical pregnancy identified which will be the end-point of the study.	Drug	Control Arm, Study Arm

Primary outcome

No.of top quality embryos produced in both the arms, study arm and control arm.
Time frame: 2 weeks
1. 4-cell embryos on day 2 of fertilization in both,Study arm and Control arm. 2. 8-cell embryos on day 3 of fertilization in both Study arm and Control arm. 3. Blastocyst embryos on day 5 or day 6 of fertilization in both Study arm and Control arm.

1 secondary outcome

Clinical pregnancy
Time frame: 6 weeks after embryo transfer (ET)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
Results publication: PubMed 18765009Lemmen JG, Agerholm I, Ziebe S. Kinetic markers of human embryo quality using time-lapse recordings of IVF/ICSI-fertilized oocytes. Reprod Biomed Online. 2008 Sep;17(3):385-91. doi: 10.1016/s1472-6483(10)60222-2.

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.

Hrishikesh D Pai, M.D. principal investigator

Bloom IVF and Fertility Centre

Manchi R Bharucha, Ph.D. study director

Bloom IVF and Fertility Centre

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing recombinant Follicle Stimulating Hormone (rFSH) in people with Embryo/Fetus Death and Blastocyst Disintegration, run by Bloom IVF and Fertility Centre at 1 site in India.

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 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2013. 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 India. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

No.of top quality embryos produced in both the arms, study arm and control arm. (time frame: 2 weeks). 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 NCT01760278, which also lists 1 linked publication.

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 4 Jan 2013.