NCT01695096

Brief Summary

To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly ongoing pregnancy rate between high humidity incubators and humidity free incubators

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

September 24, 2012

Last Update Submit

June 28, 2016

Conditions

Ongoing Pregnancy Rate

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    assessing the ongoing pregnancy rate and its difference between the 2 study arms.

    18 months

Study Arms (2)

The Embryos will be cultured on a humidity free incubator

EXPERIMENTAL

We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.

Other: The Embryos will be cultured on a humidity free incubator

The Embryos will be cultured on a >95% humidity incubator

PLACEBO COMPARATOR

We will set the humidity level to \> 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.

Other: The Embryos will be cultured on a >95% humidity incubator

Interventions

The Embryos will be cultured on a humidity free incubatorOTHER

We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.

The Embryos will be cultured on a humidity free incubator
The Embryos will be cultured on a >95% humidity incubatorOTHER

We will set the humidity level to 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.

The Embryos will be cultured on a >95% humidity incubator

Eligibility Criteria

Age18 Years - 33 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \< 33 years, BMI\<30,
  • Normo Responder(\>8 MII)
  • Fresh Cycle
  • Ist attempt
  • Normal or mild oligoasthenoteratozoospermia.

You may not qualify if:

  • Testicular sperm
  • \< 8 MII collected
  • difficult transfer cycle
  • Endometriotic patients
  • Poor Endometrium \< 8mm diameter at Ovum Pickup
  • any other medical diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gannah IVF unit, Gannah Hospital

Giza, Giza Governorate, 12345, Egypt

Location

IbnSina IVF unit, IbnSina Hospital, El Areef Square

Sohag, Sohag Governorate, 12345, Egypt

Location

Related Publications (1)

  • Fawzy M, AbdelRahman MY, Zidan MH, Abdel Hafez FF, Abdelghafar H, Al-Inany H, Bedaiwy MA. Humid versus dry incubator: a prospective, randomized, controlled trial. Fertil Steril. 2017 Aug;108(2):277-283. doi: 10.1016/j.fertnstert.2017.05.036. Epub 2017 Jun 23.

    PMID: 28651960DERIVED

Related Links

Study Officials

  • Muhammad F. Abdel-Raheem, Lab Director

    IBNSINA IVF Center

    PRINCIPAL INVESTIGATOR

  • Muhammad El Hady, Lab Director

    Ganna Hospital

    PRINCIPAL INVESTIGATOR

  • Mohamed Y. Abdel-Rahman, M.D.

    IBNSINA IVF center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Laboratory Director

Study Record Dates

First Submitted

September 24, 2012

First Posted

September 27, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

EG(2)