Quality of life, psychosocial and physical wellbeing among 1023 women during their first ART treatment: Secondary outcome to a RCT comparing GnRH-antagonist and GnRH-agonist protocol

Women in gonadotropin-releasing hormone (GnRH)- antagonist protocol rated psychosocial and physical well-being during first assisted reproductive technology treatment better than did women in GnRH-agonist protocol. However, the one item on self-reported quality of life was rated similarly.

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Volume 109, Issue 1, Pages 154–164

Authors:

Mette Toftager, M.D., Ph.D., Randi Sylvest, M.Sc., Lone Schmidt, M.D., Ph.D., D.M.Sc., Jeanette Bogstad, M.D., Kristine Løssl, M.D., Ph.D., Lisbeth Prætorius, M.D., Anne Zedeler, Ph.D., Thue Bryndorf, M.D., D.M.Sc., Anja Pinborg, M.D., D.M.Sc.

Abstract:

Objective

To compare self-reported quality of life, psychosocial well-being, and physical well-being during assisted reproductive technology (ART) treatment in 1,023 women allocated to either a short GnRH antagonist or long GnRH agonist protocol.

Design

Secondary outcome of a prospective phase 4, open-label, randomized controlled trial. Four times during treatment a questionnaire on self-reported physical well-being was completed. Further, a questionnaire on self-reported quality of life and psychosocial well-being was completed at the day of hCG testing.

Setting

Fertility clinics at university hospitals.

Patient(s)

Women referred for their first ART treatment were randomized in a 1:1 ratio and started standardized ART protocols.

Intervention(s)

Gonadotropin-releasing hormone analogue; 528 women allocated to a short GnRH antagonist protocol and 495 women allocated to a long GnRH agonist protocol.

Main Outcome Measure(s)

Self-reported quality of life, psychosocial well-being, and physical well-being based on questionnaires developed for women receiving ART treatment.

Result(s)

Baseline characteristics were similar, and response rates were 79.4% and 74.3% in the GnRH antagonist and GnRH agonist groups, respectively. Self-reported quality of life during ART treatment was rated similar and slightly below normal in both groups. However, women in the GnRH antagonist group felt less emotional (adjusted odds ratio [AOR] 0.69), less limited in their everyday life (AOR 0.74), experienced less unexpected crying (AOR 0.71), and rated quality of sleep better (AOR 1.55). Further, women receiving GnRH agonist treatment felt worse physically.

Conclusion(s)

Women in a short GnRH antagonist protocol rated psychosocial and physical well-being during first ART treatment better than did women in a long GnRH agonist protocol. However, the one item on self-reported general quality of life was rated similarly.

Clinical Trial Registration Number

NCT00756028.


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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

1 Comments

Go to the profile of Micah J Hill
Micah J Hill over 2 years ago

Thank you for your paper.  While your abstract highlights the significant differences in outcomes between the GnRH agonist and antagonist group, my interpretation of your data is more on the side that there was little clinically meaningful difference between the group.

1. For example the abstract and main paper highlight the AOR differences, but do not discuss  the absolute differences.  The abstract highlights that GnRH antagonist subjects were less emotional with an AOR of 0.69.  In Supplementary table 2, the 50.2% of patients in the antagonist group felt more emotional to a greater or some extent versus 53.3% in the agonist group.  So this is an absolute risk difference of 3.1%.  In clinical context, I would have to treat 33 patients with a GnRH agonist to have 1 additional case of a patient feeling more emotional.  Highlighting the statistically significant AOR may overstate what to me is a clinically small impact.  The absolute risk difference and NNH highlight these differences in a more clinically useful light.  

2. You stated that there was no correction for multiple comparisons as this was an exploratory analysis.  I think this is an important fact to emphasize.  There are at least 70 comparisons made, which gives the study a 97% chance of having a type I error.  

3. The overall quality of life rating was similar between the 2 groups.  It was only in these additional 70 comparisons that a few significant differences came to light.

So my interpretation of your data is that the two groups were similar in regards to quality of life.  This is clinically reassuring to make the choice of which protocol to utilize based on other medical factors.