Assessment of Implantation Potential of Embryos by Time-lapse Technology

NCT01760278 | Unknown Phase 4 DMC

• 2 other identifiers: Time-lapse monitoringStudy of embryo morphokinetics
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the Embryoscope,through latest software.
3. 3.Embryoviewer also identifies embryos for transfer, freezing and to be discarded.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (1)

• Clinical pregnancy

  6 weeks after embryo transfer (ET)

Other Outcomes (1)

• No. of mature M2 oocytes obtained

  2 weeks

Study Arms (2)

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.

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.

Drug: recombinant Follicle Stimulating Hormone (rFSH)

Interventions

recombinant Follicle Stimulating Hormone (rFSH) DRUG

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.

Also known as: Gonal-F, Progesterone vaginal, Ovitrell 250mcg, Cetrorelix 0.25 mg

Control Arm; Study Arm

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bloom IVF and Fertility Centre: lead
• Padmashree Dr. D. Y. Patil Medical College: collaborator

Study Sites (1)

Lilavati Hospital and Research Center, IVF department

Mumbai, Maharashtra, 400050, India

Location

Related Publications (1)

• 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.

  PMID: 18765009 RESULT

MeSH Terms

Conditions

Stillbirth; Embryo Loss; Aneuploidy

Interventions

Glycoprotein Hormones, alpha Subunit; follitropin alfa; cetrorelix

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abortion, Spontaneous; Chromosome Aberrations

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Hrishikesh D Pai, M.D.

  Bloom IVF and Fertility Centre

  PRINCIPAL INVESTIGATOR

• Manchi R Bharucha, Ph.D.

  Bloom IVF and Fertility Centre

  STUDY DIRECTOR

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 26, 2012
• First Posted: January 4, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

IN (1)