High Versus Free Humidity Incubators; A Randomized Clinical Trial
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
When the IVF started the majority of incubators designed to support high humidity because the designers and IVF specialists believed that the humidity will maintain stable ph and Temp.
Recent reports suggest that humidity is recommended and the others suggest no difference So we decide to go for this RCT. Nevertheless; high humidity is maintained in vivo (uterus and fallopian tubes) due to the fluid content and stable body temperatures at 37°C. David McCulloch reported 15% reduction of the miscarriage rate after changing the humidity from 76% to 100% (Textbook of Assisted Reproductive Techniques: Laboratory Perspectives, Fourth Edition). Some embryologists claim that the humidity free incubators may increase the chance of chemical pregnancy and early fetal loss (Private center IbnSina IVF, Sohag, Egypt. unpublished data). This observations are never tested in a well designed randomized clinical trial (RCT) to eliminate the probability of chance and to reach a solid evidence.
The question that should be asked : is high humidity culture should be applied or there is no difference between dry and high humidity culture conditions?
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Giza, Egypten, 12345
- Gannah IVF unit, Gannah Hospital
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Sohag, Egypten, 12345
- IbnSina IVF unit, IbnSina Hospital, El Areef Square
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- < 33 years, BMI<30,
- Normo Responder(>8 MII)
- Fresh Cycle
- Ist attempt
- Normal or mild oligoasthenoteratozoospermia.
Exclusion Criteria:
- Testicular sperm
- < 8 MII collected
- difficult transfer cycle
- Endometriotic patients
- Poor Endometrium < 8mm diameter at Ovum Pickup
- any other medical diseases
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: The Embryos will be cultured on a humidity free incubator
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.
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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.
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Placebo komparator: The Embryos will be cultured on a >95% humidity incubator
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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ongoing pregnancy rate
Tidsramme: 18 months
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assessing the ongoing pregnancy rate and its difference between the 2 study arms.
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18 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Muhammad El Hady, Lab Director, Ganna Hospital
- Studieleder: Mohamed Y. Abdel-Rahman, M.D., IbnSina IVF Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ibnsinaH (Anden identifikator: ibnsinaH)
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