NCT03105518

Brief Summary

The central objective of this study will be to evaluate the relationship between estrogen levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.

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
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2014

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 5, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

12.3 years

First QC Date

October 5, 2014

Results QC Date

April 16, 2017

Last Update Submit

August 2, 2022

Conditions

Oocyte RetrievalPostoperative Pain

Keywords

assisted reproductionpostoperative painopioid

Outcome Measures

Primary Outcomes (1)

  • Amount of Discomfort

    Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort.

    PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3

Secondary Outcomes (1)

  • Amount of Discomfort Following Discharge Until Embryo Transfer

    After 1 hrs but less than 3 days

Study Arms (1)

Analgesia options

EXPERIMENTAL

Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.

Drug: FentanylDrug: AcetaminophenDrug: Oxycodone

Interventions

FentanylDRUG

0.5, 1 mcg/kg

Also known as: Sublimaze
Analgesia options
AcetaminophenDRUG

Single + Oxycodone

Also known as: Tylenol
Analgesia options
OxycodoneDRUG

With Acetaminophen

Also known as: Percocet
Analgesia options

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) I to III health status (moderate systemic disease),
  • Age between 18 and 50 yrs
  • Undergoing oocyte retrieval with intravenous general anesthesia.

You may not qualify if:

  • Refuse or withdraw their consent
  • Fail to adequately respond to IVF stimulations medications, and thus are not eligible for oocyte retrieval.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Harnett MJ, Bhavani-Shankar K, Datta S, Tsen LC. In vitro fertilization-induced alterations in coagulation and fibrinolysis as measured by thromboelastography. Anesth Analg. 2002 Oct;95(4):1063-6, table of contents. doi: 10.1097/00000539-200210000-00050.

    PMID: 12351295RESULT

  • Bader AM, Datta S, Moller RA, Covino BG. Acute progesterone treatment has no effect on bupivacaine-induced conduction blockade in the isolated rabbit vagus nerve. Anesth Analg. 1990 Nov;71(5):545-8. doi: 10.1213/00000539-199011000-00016.

    PMID: 2221417RESULT

  • Datta S, Lambert DH, Gregus J, Gissen AJ, Covino BG. Differential sensitivities of mammalian nerve fibers during pregnancy. Anesth Analg. 1983 Dec;62(12):1070-2.

    PMID: 6650889RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

FentanylAcetaminophenOxycodoneoxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

No limitations or caveats noted for this study.

Results Point of Contact

Title
Lawrence Tsen, MD
Organization
Brigham and Women's Hospital/Harvard Medical School
ltsen@bwh.harvard.edu
617.732.8216

Study Officials

  • Lawrence C Tsen, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Assessment of immediate and delayed postoperative pain
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair, Faculty Development and Education; Associate Professor

Study Record Dates

First Submitted

October 5, 2014

First Posted

April 10, 2017

Study Start

March 1, 2011

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 3, 2022

Results First Posted

December 5, 2017

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)