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Trial record 78 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

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ClinicalTrials.gov Identifier: NCT01815138
Recruitment Status : Completed
First Posted : March 20, 2013
Results First Posted : September 25, 2017
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lawrence Engmann, UConn Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ovarian Hyperstimulation Syndrome
Intervention Drug: hCG
Enrollment 89
Recruitment Details  
Pre-assignment Details All patients that met initial study criteria were enrolled and consented before starting ovarian stimulation. Final randomization occurred during stimulation. Therefore patients who were enrolled and consented may drop out before randomization, either because they did not meet the final inclusion criteria in did not undergo IVF.
Arm/Group Title hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Hide Arm/Group Description

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Period Title: Overall Study
Started 34 37
Completed 26 31
Not Completed 8 6
Reason Not Completed
Withdrawal by Subject             0             1
Physician Decision             8             5
Arm/Group Title hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger Total
Hide Arm/Group Description

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Total of all reporting groups
Overall Number of Baseline Participants 26 31 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 31 participants 57 participants
31.3  (3.3) 32.2  (3.4) 31.8  (3.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 31 participants 57 participants
Female
26
 100.0%
31
 100.0%
57
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  "kg/m^2"
Number Analyzed 26 participants 31 participants 57 participants
26.3  (4.8) 27.4  (5.5) 26.9  (5.2)
Anti Mullerian Hormone (AMH)  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 26 participants 31 participants 57 participants
8.3  (5.8) 8.4  (4.9) 8.35  (5.2)
Follicle Stimulating Hormone (FSH)  
Mean (Standard Deviation)
Unit of measure:  IU/L
Number Analyzed 26 participants 31 participants 57 participants
5.6  (1.7) 5.2  (1.6) 5.5  (2.1)
1.Primary Outcome
Title Ongoing Pregnancy
Hide Description Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .
Time Frame Through time of study completion, on average 1-2years
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol analysis
Arm/Group Title hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Hide Arm/Group Description:

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Overall Number of Participants Analyzed 26 31
Measure Type: Number
Unit of Measure: participants
15 19
2.Secondary Outcome
Title Ovarian Hyperstimulation Syndrome
Hide Description Evaluation of symptoms and signs of OHSS at 9 days after trigger of oocyte maturation. Patients who also present with symptoms of OHSS wil also be evaluated for OHSS within 4 weeks after oocyte maturation.
Time Frame Within 4 weeks of oocyte retrieval
Hide Outcome Measure Data
Hide Analysis Population Description
Women with normal or high response to IVF, peak estradiol on day of trigger less than 4000 pg/mL.
Arm/Group Title hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Hide Arm/Group Description:

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Overall Number of Participants Analyzed 26 31
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.8%
3
   9.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection hCG Given at Time of GnRHa Trigger, hCG Given 35 Hours After GnRHa Trigger
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.05
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Markers of Corpus Luteum Function
Hide Description A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.
Time Frame Within 60 days after trigger of oocyte maturation
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of women included in larger study, normal or high responders, peak estradiol level less than 4000 pg/mL on day of trigger.
Arm/Group Title hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Hide Arm/Group Description:

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
Early luteal 17-OH-Progesterone 13.68  (11.0) 21.77  (8.5)
Day 16 Prorenin 1.13  (0.8) 2.22  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection hCG Given at Time of GnRHa Trigger, hCG Given 35 Hours After GnRHa Trigger
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Proportion of Patients With Abdominal Distension
Hide Description Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.
Time Frame Within 2 weeks after trigger of oocyte maturation
Hide Outcome Measure Data
Hide Analysis Population Description
Some patients did not complete the questionnaire. Abdominal distension analyzed
Arm/Group Title hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Hide Arm/Group Description:

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Overall Number of Participants Analyzed 20 27
Measure Type: Count of Participants
Unit of Measure: Participants
Abdominal distension
2
  10.0%
11
  40.7%
abdominal pain
1
   5.0%
9
  33.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Hide Arm/Group Description

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

All-Cause Mortality
hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)      0/31 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      1/31 (3.23%)    
Pregnancy, puerperium and perinatal conditions     
Ectopic Pregnancy  [1]  1/26 (3.85%)  1 1/31 (3.23%)  1
Indicates events were collected by systematic assessment
[1]
Patient diagnosed with un-ruptured ectopic pregnancy and required a laparoscopy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
hCG Given at Time of GnRHa Trigger hCG Given 35 Hours After GnRHa Trigger
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/31 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lawrence Engmann
Organization: UConn Helth
Phone: 8605258283
EMail: lengmann@uchc.edu
Layout table for additonal information
Responsible Party: Lawrence Engmann, UConn Health
ClinicalTrials.gov Identifier: NCT01815138     History of Changes
Other Study ID Numbers: 13-098-3
First Submitted: March 16, 2013
First Posted: March 20, 2013
Results First Submitted: April 17, 2017
Results First Posted: September 25, 2017
Last Update Posted: October 26, 2018